Essential Responsibilities

• Establish and maintain an understanding of Unicep’s products and services and how they are applied in each market segment we serve.
• Serve as point of contact for assigned customers/programs.
• Provide project updates to supported APMs, PMs, and Management as necessary.
• Assist with the administration of the Quote process with a basic understanding of cost drivers, customer business needs and Unicep’s sales processes. Quote process entails interaction with quote team, suppliers, customers and sales executives.
• Input quote data into spreadsheet form for analysis and reporting.
• Process and enter Sales Orders.
• Assist APMs, PMs, and Management to administer customer contracts.
• Assist with New Product Introduction (NPI), product transfers, and end-of-life activities.  Generate and tracks cross-functional action item lists and ensure alignment with customer expectations.
• Assist with ongoing production for established programs by leading cross-functional teams, as required, to ensure that programs are conducted in accordance with the requirements of sales orders and program objectives, elevating unresolved issues to management. 
• Assist APMs and PMs with managing cash flow, budgets, forecasts, profit & loss, program timelines, resources, and key milestones.
• Write Work Orders and obtain required signatures.
• Identify and support development of organic growth opportunities with existing customer base.
• Generate, maintain and publish reports on cost, margins, and inventory levels.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Maintain regular attendance.
• Adhere to company safety requirements.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor's degree in engineering or business preferred.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Basic knowledge of cost accounting and materials procurement preferred.
• Proven proficiency in managing timelines.
• Ability to read, analyze, and interpret common scientific and technical publications and reports.
• Ability to clearly and effectively communicate in both oral and written formats.
• Ability to effectively present information and respond to questions.
• Proficient with applied business and economic mathematics and analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract and concrete variables.
• Proficient in Microsoft Office products including Word, Excel & Project.
• Experience working in CRM databases with proficiency in Salesforce preferred.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Frequently required to walk.
• Frequently required to sit.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.
• Ability to travel by air or car to meet with customers.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Establish and maintain understanding of Unicep’s products and services and how they are applied in each market segment we serve.
• Serve as primary or secondary point of contact for assigned customers/programs.
• Develop a keen understanding of customer requirements by market segment
• Administer the Quote process with a fundamental understanding of cost drivers, customer business needs and Unicep sales processes. Quote process entails interaction with quote team, suppliers, customers and sales executives.
• Successfully acquire customers through conversion of qualified leads.
• Work with Management to negotiate and administer customer contracts.
• Manage New Product Introduction (NPI), product transfers, and end-of-life activities.  Generate and track cross-functional action item list and ensure alignment with customer expectations.
• Sustain ongoing production for established programs by leading cross-functional teams, as required, to ensure that programs are conducted in accordance with the requirements of sales orders and program objectives, elevating unresolved issues to management. 
• Manage cash flow, budgets, forecasting, profit & loss, program timelines, resources, and key milestones.
• Identify and develop organic growth opportunities with existing customer base.
• Generate, maintain and publish reports on cost, margins, manufacturing variances, and inventory levels.
• Advise management of program status on a regular basis.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Travel to Unicep Sandpoint manufacturing facility and to customer sites as necessary to support projects.
• Maintain regular attendance.
• Adhere to company safety requirements.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor’s degree in engineering or business, or an equivalent combination of education and experience.
• 2-4 years’ experience in engineering, high volume assembly management, procurement, or finance; or an equivalent combination of education and experience.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations.
• Knowledge of cost accounting, profit & loss statements and materials procurement.
• Proven proficiency in managing timelines.
• Ability to read, analyze, and interpret common scientific and technical publications and reports.
• Ability to clearly and effectively communicate in both oral and written formats.
• Ability to effectively present information and respond to questions.
• Proficient with applied business and economic mathematics and analysis.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Proficient in Microsoft Office products including Word, Excel, and Project.
• Experience working in CRM databases with proficiency in Salesforce preferred.
• Fundamental understanding of quote process.
• Fundamental understanding of cost drivers in business.
• Excellent interpersonal skills.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Frequently required to walk.
• Frequently required to sit.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.
• Ability to travel by air or car to meet with customers.

Essential Responsibilities

• Lead work centers and production lines as necessary.
• Maintains assigned machinery.
• Sustains awareness of production schedule and needs.
• Independently operate several types of production machinery after the successful completion of training and certification.
• Monitors production equipment to ensure a quality product.
• Perform machine set up and changeovers on various equipment and production lines.
• Follow established quality requirements for each product.
• Complies with all procedural requirements.
• Performs troubleshooting, adjustments, and preventative maintenance of production machinery.
• Reads and interprets equipment manuals and work orders to perform required maintenance and service.
• Work with Quality Control to ensure written documentation for production runs is complete, correct, and in compliance with company Good Documentation Practices and government regulations.
• Identifies and implements necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Follows guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Adhere to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Adhere to all company policies, procedures, and safety requirements.
• Maintain good housekeeping and a clean work area.
• Promote teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

• Associate’s degree or certificate in mechanical or industrial maintenance preferred. or equivalent.
• 2 – 4 years of manufacturing/production experience.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to read and interpret written policies and procedures.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Ability to complete paperwork fully and correctly.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Occasionally required to sit.
• Frequently required to talk and hear.
• Frequently required to walk.
• Required to stand for 3 – 4 hours at a time.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Frequently required to bend at waist and knees.
• Frequently required to reach.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.
• Frequently required to work with products that contain chemicals or may contain hazardous materials.  MSDS sheets are required.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Works on a production line packaging products, following written guidelines and specifications for each product.
• Independently operates production machinery after the successful completion of training and certification.
• Follows established quality requirements for each product.
• Adheres to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Cross train to other work stations to enable rotation of work.
• Adheres to all company policies and procedures.
• Maintains good housekeeping and a clean work area.
• Promotes teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• Regular attendance is an essential function of this position
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adheres to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Prior experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Prior experience working on a production line preferred.
• Ability to read and interpret written policies and procedures.
• Ability to complete paperwork correctly.
• Ability to add, subtract, multiply and count.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Ability to recognize good quality and perform to quality standards.

PHYSICAL REQUIREMENTS:

• Varied position throughout shift, including standing and/or sitting for up to 2 hours at a time.
• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to lift and/or move up to 25 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Good manual dexterity.
• Ability to grasp small objects.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Schedule and manage third-party contractors, ensuring compliance with all company policies and procedures, and regulatory requirements.
• Analyze, implement and train layout of equipment, workflow, production methods and workforce utilization and implement processes and procedures to maximize efficiency.
• Work autonomously to re-design, repair or replace in-process production program equipment, production control hardware, and tooling.
• Develop and document Standard Operating Procedures (SOPs), Work Instructions, and troubleshooting processes, methods, tooling and production controls for new programs. Train Manufacturing Engineers and Machine Technicians in these areas.
• Follow guidelines to assure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Identify and implement necessary documentation for compliance and interact with QA to ensure compliance.
• Write procedures and train others on the operation of new or existing equipment.
• Stay informed concerning new manufacturing technology and equipment, and investigate their potential application. Recommend incorporation of new technology for company applications where feasible and practical.
• As part of the New Product Introduction process, review material Safety Data Sheets for safety compliance.
• Participate in the process to quote new products.
• Prepare specifications and source new equipment.
• Prepare User Requirement Specifications/FS for new equipment.
• Perform validation document review for new equipment.
• Plan and execute the preventive maintenance program.
• Lead continuous improvement efforts using lean manufacturing principles.
• Prepare and manage capital projects including identifying scope, cost, milestones, etc.
• Serve as a key resource for safety related issues with the goal of meeting/exceeding OSHA requirements for a safe workplace.

Minimum Requirements

• Bachelors degree in Mechanical Engineering, or a related field, or an equivalent combination of education and experience
• 3-5 years manufacturing experience
• Demonstrated ability to lead people and get results through others
• Knowledge of building codes
• Preventive maintenance experience
• Ability to work independently with minimal supervision
• Strong mechanical aptitude and working knowledge of electrical and mechanical systems
• Good troubleshooting and diagnostic skills
• Ability to prioritize workload to meet established timelines
• Prior experience in FDA manufacturing facility and GMP regulations preferred

Essential Responsibilities

Minimum Requirements

• 2-4 years of maintenance technician experience.
• Associate’s degree or certificate in mechanical or industrial maintenance preferred.
• Knowledgeable in pneumatics, electrical, and mechanical systems diagnosis.
• Ability to use a variety of hand, and diagnostic tools.
• Frequency Drive, and PLC experience is a plus.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Ability to travel by car to support multiple-site facility.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

Essential Responsibilities

• Responsible for the receipt, storage, and shipping of raw materials, finished goods, and other supplies to support company operations.

• Unloads trucks, as needed; checks in product, matches purchase orders to product, and distributes to appropriate person/department.

• Processes shipping orders or requisitions, as requested, ensuring shipping timelines are met and the most cost-effective shipping method is used.

• Moves raw materials and other incoming items to designated areas for processing.

• Moves finished goods to designated shipping areas.  Loads trucks for shipping as needed.

• Marks materials with identifying information as required, in compliance with current Good Manufacturing Practices (GMP) regulations.

• Records amounts of materials or items received or distributed in the inventory control system.

• Sorts and places materials or items on racks, shelves, or in bins, according to product code.

• Ensures warehouse is safe and accessible for all employees.

• Assists with physical inventories, ensuring the accuracy of counts. 

• Maintains inventory levels within the warehouse as directed.

• Keeps the warehouse organized and orderly at all times.

• Transports raw materials, finished goods, and other items between the Sandpoint, Idaho, and Liberty Lake, Washington, warehouses. 

• Ensure compliance GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.

• Adheres to company safety requirements.

• Regular attendance.

• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Prior experience in a warehouse/distribution setting.

• High school diploma or equivalent.

• Forklift certified.

• Ability to work independently with little direction.

• Ability to read and interpret documents such as procedure manuals.

• Ability to perform basic math skills, including addition and subtraction.

• Ability to complete paperwork.

• Proficient with Microsoft Office products.

• Excellent interpersonal skills with the ability to communicate effectively at all levels within the organization, and with customers and vendors.

• Valid driver’s license, good driving record, and proof of auto insurance coverage.

• Ability to obtain medical card.

• Ability to drive 26’ straight truck, 26,000 gross.

• Basic computer skills, Microsoft Suite.

• Prior experience in a FDA regulated manufacturing facility preferred.

• Knowledge of GMP regulations preferred.

• CDL License required 

PHYSICAL REQUIREMENTS:

• Occasionally required to sit.

• Frequently required to talk or hear.

• Frequently required to stand or walk.

• Occasionally required to climb or squat.

• Frequently required to move and/or lift up to 25 pounds.

• Occasionally required to move and/or lift up to 50 pounds.

• Vision ability includes close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversees the daily performance of the IT systems.
• Ensures the reliability, efficiency, and confidentiality of the IT system.
• Manages the network infrastructure and connectivity, including wide area, local area, and remote access capabilities.
• Responsible for hardware maintenance, software support, network and remote backups, system upgrades and Internet support for the company.
• Utilizes enterprise resource planning (ERP) techniques for the coordination of multisite IT systems.
• Orders and sets up equipment for employee use, performing and ensuring proper installation of cables, operating systems, and appropriate software.
• Creates and maintains computer validation program, ensuring key deadlines are met.
• Develops training materials/procedures and trains users in the proper utilization of hardware and software applications.
• Troubleshoots systems problems with users to determine the root cause(s), and takes the necessary steps to resolve.  Maintains records of daily communications, problems, and actions taken.
• Develops and maintains systems with provision for continuity of operations during any disaster recovery or other emergency situations.
• Works with all departments and outside computer support vendors to provide support to all users.
• Creates and manages IT budget, adhering to company fiscal plan.
• Identifies future requirements and evaluates and recommends software and hardware to maximize productivity.  Works with management to establish requirements for new systems or modifications to current systems.  Coordinates the installation of new systems and updates to current systems.  Perform testing for all new or modified systems.
• Ensures compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Provides high level of customer service with a sense of urgency.
• Regular attendance is an essential function of this position.
• Adheres to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Computer Science or a related technical field or an equivalent combination of education and experience.
• Minimum three (3) years of IT experience.
• Working knowledge of networking systems including WAN and LAN.
• Working knowledge of Windows Operating Systems and personal computers.
• Knowledge of relational databases.
• Good analytical skills, coupled with excellent written and oral communication skills to explain technical information to system users.
• Ability to work independently with little direction.
• Ability to make sound decisions based on the needs of the business.
• Excellent project and program management skills.
•  

PREFERRED DUTIES, RESPONSIBILITIES AND SKILLS

• Experience with MAS 90 preferred.
• Experience writing reports from a database.
• Create and run routine reporting from the database.
• Design, write and implement special reports from the database.
• Experience in a FDA regulated facility preferred.
• Knowledge of GMP regulations preferred
• Ability to travel for support of both Unicep facilities..

PHYSICAL REQUIREMENTS:

• Frequently required to sit and walk.
• Frequently required to walk up and down stairs.
• Frequently required to talk and hear.
• Occasionally required to stand.
• Occasionally lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Measure, weigh, mix, and dispense chemicals while mixing product.
• Clean and sanitize mixing room equipment.
• Operate mixing room equipment.
• Review and record data.
• Maintain accurate production records, including (but not limited to) totals, number of rejects, and accounting for bulk product.
• Regular attendance is an essential function of this position
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Experience in a manufacturing setting preferred.
• Understanding of chemicals and their handling preferred.
• Ability to multitask.
• Good attention to detail.
• Ability to add, subtract, multiply, divide, and count.
• Good communication skills.
• Ability to understand and follow written and verbal procedures and instructions.
• Ability to work independently with little direction in a fast paced environment.
• Ability to work as a member of a team.
• Experience in a FDA regulated manufacturing facility preferred.
• Experience with ISO, GMP and/or GLP standards preferred.

Essential Responsibilities

• Develops, publishes, and maintains the Master Production Schedule, balancing inventory, resources and capacity. Negotiates corrective actions to product schedules when dictated by changes in business.
• Acts as liaison between Production, Engineering, Purchasing, and Sales to control the Master Schedule. Assists other production support groups in achieving corporate goals.
• Participates in new/sustaining product teams, representing materials, scheduling, and revenue concerns.
• Participates in Change Control Board (CCB) activity to ensure engineering changes are consistent with the production plans and inventories. Coordinates Engineering Change Notice effectiveness with Purchasing, Planning, and Production.
• Develops and documents internal and interface procedures to ensure consistent Master Scheduling policy, and for assembly scheduling in facilities worldwide. Works to optimize schedule to achieve corporate goals of revenue, profitability and cost savings. Reports changes to projected monthly or quarterly goals.
• Assists with system implementation issues relative to the Master Scheduling process.
• Assists Program Management in scheduling sales orders and supporting customer requirements.
• Develops and maintains planning bills of material and planning databases.
• Monitors performance to Master Schedule.
• Analyzes and updates system planning data such as lead times, safety stock, distribution resource planning, time fence, etc.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops, implements and manages quality control systems designed to ensure continuous production of all customer products and projects.  Works closely with the labs supervisor to plan, direct and coordinate the day-to-day operational activities of the microbiology and analytical labs.
• Oversees the coordination of testing with outside laboratories and internal demands, departments and customer requirements
• Works with Director of Quality and Regulatory Affairs on the quoting process for laboratory work.
• Responsible for the oversight and management of the Quality Control budget and meeting corporate goals.
• Manage the procurement, analysis and coordination of the data needed for Annual Product Reviews.
• Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, method qualifications, etc.).
• Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
• Oversee testing of water (USP), Work in progress, raw materials, environmental monitoring, and finished goods.
• Participate in audits by customers or regulatory agencies.
• Address observations or recommendations as well as implement corrective/preventive actions as needed for both internal and external audits.
• Notify the organization of Out of Specification test results and coordinates the interpretation of what the results mean and how to proceed.
• Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a testing and/or product failures.
• Meet customer expectations for timeliness of lab studies and product shipments.
• Directs the analysis and resolution of internal and/or external delays as well as identify trends, recommend improvements and implement improvement activities to achieve annual on-time objectives.
• Insure exceptional customer service to internal and external customers is provided by the laboratories.
• Regular attendance.
• Adhere to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemistry, Microbiology, or a related field.
• 5-10 years lab experience.
• Detailed knowledge of biohazard and USP requirements.

• Minimum 5 years’ experience supervising employees in an FDA regulated environment preferred.
• Must be able to pass Better Process Control School course pertaining to FDA regulations applying to low acid and acidified foods within 30 days of hire.

• Experience with ISO, GMP and/or GLP standards required.
• Experience with laboratory practices including analytical methods and microbiology methods.
• Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials.
• Knowledge of chemical terminology and units of measure.
• Ability to initiate, perform, and complete reports in a timely manner.
• Ability to work independently with little direction in a fast-paced environment.
• Ability to travel via car to support multiple facility locations.
• Good interpersonal skills.
• Ability to schedule projects and meet tight deadlines.
• Proficient in Microsoft Office Suite.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk and/or hear.
• Frequently required to stand and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
• Frequently required to work with chemicals. MSDS sheets are provided.

Essential Responsibilities

• Supervise and offer leadership to employees in accordance with policies and guidelines.
• Interview, hire, and train employees, plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints, and resolve problems as needed.
• Identify quality-related training needs and deliver training throughout the company.
• Assist with the quality management strategy and assist in setting policy, quality goals, and milestones.
• Participate in change and problem-solving teams; be an agent for compliant change.
• Administer the Corrective and Preventive Action (CAPA) program and Deviation and Nonconforming (NCR) programs against defined parameters. Ensure that CAPAs, Deviations and NCR's are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, risk mitigation, and verification of effectiveness of the plan. Log, track, and ensure that the CAPA, Deviation and NCR procedures are maintained in a compliant state.
• Administer Nonconformance system. Ensure that nonconformances are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Nonconformance procedure is maintained in a compliant state.
• Administer the Deviation system. Ensure that deviations are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Deviation procedure is maintained in a compliant state.
• Administer the Internal Audit Program. Ensure procedures are maintained, training is provided for internal auditors, annual audits scheduled, and responsibilities assigned to audit team. Coordinate the generation of corrective actions for audit findings and ensure follow up from responsible parties.
• Analyze audit data and prepare reports for management review and continuous improvement initiatives.
• Handle Customer Complaints, including: logging, tracking, investigating, and responding back to the customer.  
• Participate in regulatory and customer audits.
• Ensure compliance GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
• Minimum 5 years’ experience providing GMP regulatory compliance in Manufacturing or Quality Assurance.
• Minimum 3 years’ experience in an FDA facility.
• Prior experience in a pharmaceutical manufacturing facility.
• Knowledge of GMP, ISO 9000, and FDA requirements.
• Proven experience implementing and managing quality systems in a GMP environment.
• Auditing certification preferred.
• ASQ certification preferred.
• Prior supervisory experience.
• Excellent communication skills, both verbal and written.
• Excellent analytical and problem solving skills.
• Strong leadership skills.
• Proficient with Microsoft Office products, including Word and Excel.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established timelines.
• Excellent attention to detail and good organizational skills.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Design and draft validation protocols for processes and equipment.
• Design and draft calibration protocols for equipment.
• Create draft validation protocols.
• Execute validation and calibration documents.
• Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms.
• Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.
• Perform and document experiments to demonstrate that equipment and processes consistently function as intended to maintain regulatory compliance of the facility.
• Write draft reports based on data gathered during execution of validation documents.
• Support Engineering in compliance with FDA/ISO regulations.
• Assist with writing Standard Operating Procedures (SOPs), Preventive Maintenance procedures, and other documents for equipment and processes as needed.
• Consult with other departments on FDA/ISO regulatory compliance as requested.
• Perform initial reviews of equipment usage to determine if systems need to be re-validated or calibrated.
• Evaluate external calibration protocols and schedule external vendors for maintaining calibration needs of the organization.
• Evaluate external validation protocols.
• Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• All other responsibilities as required.

Minimum Requirements

• Bachelor’s degree in Science, Engineering, or a related field, or an equivalent combination of education and experience.
• Three years’ experience in Validation.
• One year’s experience in calibration.
• Knowledge of the Scientific Method.
• Knowledge of ISO and FDA requirements for GMP/GLP practices.
• Experience working in a FDA regulated manufacturing facility.
• Ability to work independently with minimal direction.
• Ability to prioritize workload to meet established deadlines.
• Familiar with Chemistry, Microbiology, and Engineering terminology.
• Ability to perform basic statistical calculations and analysis.
• Experience creating and maintaining documentation and reporting.
• Proficient in Microsoft Office.
• External qualification to a recognized certifying organization for calibrations is a plus, but is not required.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Required to sit for 3-4 hours at a time.
• Frequently required to walk and stand.
• Occasionally lift up to 25 pounds.
• Fine motor control to grasp small objects.
• Vision includes close vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Working as part of a cross-functional team, participate in new product development projects with new and existing customers as directed by R&D Manager.
• Adhere to project activities and timelines. Support R&D Manager in communications regarding project activities and deliverables.
• Generate, maintain, and review product development documents, batch records, and other related documents.
• Understand customer needs, competitive forces, changing technology, and available resources.
• Support R&D efforts to identify market needs as they relate to research and development projects.
• Develop experimental designs, perform the experiments, and report on the results.
• Participate in product development for new and current products, including planning, scheduling, documenting, and identifying necessary resources. 
• Review competitive information and technology related material in order to stay current with industry developments.
• Regular attendance.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.

Minimum Requirements

MINIMUM REQUIREMENTS

• Bachelor’s degree in Chemistry or Biology or a combination of equivalent experience and education/training.

• 3-5 years’ experience in a FDA-regulated manufacturing setting, including mixing and formulation experience.

• Demonstrated ability to lead people and get results through others.
• Ability to organize and manage multiple priorities.
• Ability to respond to common inquiries and participate in response to complaints from customers and regulatory agencies.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Excellent interpersonal and communication skills.
• Knowledge of quality, GMP, ISO 9000, FDA and OSHA regulations.
• Proficient with Microsoft Office products, including Word and Excel.
• Ability to recognize good quality and perform to quality standards.

• PHYSICAL REQUIREMENTS
• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Frequently required to lift and/or move up to 25 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.
• Frequently work with chemicals. MSDS sheets are required.
• Ability to wear a respirator.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support the day-to-day Production activities under the direction of the Production Supervisor, ensuring compliance with established and approved policies and procedures.
• Lead Production employees in the manufacture and packaging of products.
• Provide leadership for employees through effective communications, coaching, and training and development.
• Ensure appropriate staffing levels based on production needs. Assist with the creation and maintenance of the weekly production schedule.
• Effectively use labor, materials, and support services to meet quality standards, production schedules and profit plans.
• Provide technical guidance for Production Operators, including troubleshooting.
• Provide Production metrics as requested.
• Promote and participate on Continuous Improvement Teams (CIT).
• Lead by example by promoting good manufacturing principles.
• Ensure compliance with company standards for cost control, waste reduction, quality, OSHA, safety, and complete and on-time delivery at the lowest possible cost.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Experience in a FDA manufacturing facility preferred.
• Must be able to pass Better Process Control School course pertaining to FDA regulations applying to low acid and acidified foods within 30 days of hire.
• Supervisory experience in a manufacturing environment preferred.
• Good knowledge of GMP regulations.
• Experience with materials and inventory management, production scheduling, and preventive maintenance preferred.
• A demonstrated ability to lead people and get results through others.
• Process manufacturing experience preferred.
• Knowledge of lean manufacturing techniques preferred.
• Excellent interpersonal and communication skills.
• Excellent project management skills.
• Proficient with computer systems and the ability to use programs including word processing, spreadsheets, databases, modeling, graphics, and presentation software.

PHYSICAL REQUIREMENTS:

• Frequently required to stand and walk.
• Frequently required to sit, talk, and hear.
• Frequently required to lift and/or move up to 20 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Collaborate with internal functional groups and customers to develop product documentation.
• Perform or assist with troubleshooting on new and existing products.
• Design of fixtures and ancillary items as required.
• Development and implementation of experiments to assess components and finished goods.
• Drawing creation and modification using applicable software packages (CAD, Corel).
• 3D modeling and adherence to creation practices.
• Ability to utilize on-line resources to gather information and specifications.
• Develop and apply knowledge of specifications pertinent to materials, packaging components and finished goods.
• Has signature authority for Change Control approval, check and data entry check on engineering changes. Manages Design Control documentation to FDA and other regulatory requirements.
• Acts as focal for engineering documentation creation and product engineering supply to all other service groups within the company Program Management, Sales and Marketing, Purchasing, Design Engineering, Scheduling, Manufacturing Engineering, and Quality. Ensures all necessary documentation is in place prior to phase gates.
• Executes and manages design engineering projects.
• Manage schedule, and specifications on a major engineering projects.
• Support training and development of product engineering team (remote sites).
• Attend meetings as needed to support organization activity.
• Interface with customers as required.
• Travel between Unicep facilities required as an essential function of this position.
• Regular attendance.
• Other duties as assigned. 

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor's degree in Engineering.
• Zero to four years progressive experience in a product engineering or related engineering discipline.
• Ability to operate and have knowledge in using SolidWorks software.  Must be able to define problems, collect data, establish facts, draw valid conclusions, and demonstrate the ability to determine critical parameters
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Demonstrated ability with technical writing. Ability to communicate effectively, both orally and in writing to management and technical staff audiences. Ability to stand in front of small to large technical audiences and provide training.
• Demonstrated organizational skills, with the ability to handle and prioritize multiple projects simultaneously in a timely manner in a fast-paced environment.
• Must have knowledge of use and operation of MS Office, email, and Internet.
• Must have a high level of interpersonal skills to handle sensitive and confidential situations and materials. Position continually requires demonstrated poise, tact, and diplomacy.
• Ability to work both independently with little direction and as part of a team.
• Experience in a FDA-regulated facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Frequently required to sit and walk.
• Frequently required to walk up and down stairs.
• Frequently required to talk and hear.
• Fine motor control to grasp and manipulate objects.
• Occasionally required to bend at the waist and knees.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

• Coordinating production workflow for one or multiple products
• Planning and prioritizing operations to ensure maximum performance and minimum delay
• Analyzing manpower, equipment and raw materials needed to cover production demand.
• Material analysis to support planned production schedules.
• Cross train with Master Scheduler(s) for optimum production capacity and utilization.
• Perform yield analysis to Program Management for research and capability for bulk.
• Work cross-functionally with production supervisors and production schedule to ensure the best utilization of machine capacity and improve manufacturing time and provide a detailed plan to the team to meet customer expectations.
• Identify concerns and constraints and communicate with the production team and propose solutions.
• Assist Master Scheduler(s) in expedite planning and priority setting to meet customer expectations and milestones.
• Ensures compliance with company standards for cost control, waste reduction, quality, safety, and complete and on-time delivery at the lowest possible cost.
• Coordinates with other departments to ensure schedules are met and ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Ability to travel by car to support multiple facility organization.
• Other duties as assigned.

Minimum Requirements

• 2 – 4 years proven production planner in a manufacturing setting.
• Excellent knowledge of production planning and quality control principals.
• Experience with Manufacturing Resource Planning systems Sage Mas90 preferred.
• Working knowledge of MS Office applications
• Good at math and statistics.
• Detail orientation with strong organizational and problem-solving skills.
• Excellent communication skills, both oral and written.
• College degree a plus
• APICS certification preferred

Essential Responsibilities

• Works closely with Manufacturing and Automation Engineering to create, update, and maintain equipment User Requirements Specifications.
• Support design, fabrication, and upgrades for manufacturing equipment as directed by Automation Engineering Manager.
• Troubleshooting and corrective actions to support equipment issues. Provide guidance and training for maintenance technicians and operations on related activities.
• Works closely with Automation Engineering Manager and PLC Engineer to facilitate machine upgrades and modifications.
• Works with Manufacturing and Maintenance to maintain accuracy, location, and completion of equipment manual, work instructions, and log books.
• Provide guidance on machine maintenance requirements.
• Ability to collect data from multiple sources and propose prioritization to fix, standardize, and incorporate new capabilities for manufacturing equipment.
• Project technical lead, with responsibility for project management activities.
• Work with outside vendors and consultants.
• Draft specifications for mechanical, electrical, and control components.
• Support new company initiatives in the areas of Manufacturing and Operations.
• Support compliance with FDA, ISO, OSHA, and all other regulatory requirements in compliance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Electrical, Automation, Robotics, Mechanical, or Computer engineering, or equivalent education and experience.
• Five or more years’ experience in Engineering with strong automation design and troubleshooting responsibilities.
• Experience with eMaint CMMS is preferred.
• Experience with SolidWorks is preferred.
• Experience with electrical wiring.
• Experience with technical writing.
• Experience in PLC logic and programming is desirable.
• Experience in a FDA regulated manufacturing facility preferred.
• Good communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Proficient in Microsoft Office products.
• Proven ability to develop and implement standard engineering practices, as well as provide detailed documentation upon completion.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to stoop or bend.
• Regularly required to lift and/or move up to 20 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
•  

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Establish and maintain understanding of Unicep’s products and services and their applications in each market segment we serve.
• Schedule and execute marketing campaigns, including coordination of ad placements and creation and distribution of electronic materials.
• Maintain Unicep website to ensure it reflects current marketing and sales objectives.  
• Perform website analysis and keyword research to inform SEO strategies.
• Maintain marketing materials for Unicep including (but not limited to) display ads, brochures, product samples, and promotional items.
• Engage with contract service providers to support the design and creation of Unicep marketing materials.
• Collaborate with Business Development to develop and implement sales/marketing programs to support sales and expand Unicep’s customer base.
• Assist in the development of the annual marketing budget.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Perform other duties as assigned.
• Regular attendance is an essential function of this position.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Marketing, Business, or related field or a combination of equivalent education and experience required.
• Minimum 2 years’ experience in Marketing or Business Development
• Strong organization skills with an ability to work independently with little direction.
• CRM experience desired with Salesforce experience preferred.
• Proficiency with Microsoft Office products required.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Regularly required to lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

• Perform in-process and final quality inspections of product on an as-needed basis.

• Perform incoming materials inspection of customer supplied product and raw materials.

• Interpret and execute Standard Operating Procedures (SOPs) and Work Instructions.

• Create LIMS monographs and receiving specifications.

• Release receiving materials.

• Communicate with program management for product related issues.

• Communicate with lab personnel to ensure timely test completion.

• Work directly with Batch Record Reviewer and Master Scheduler to ensure timely completion of material release.

• Provide monthly metrics for receiving inspection and releases to the Quality Manager.

• Prepare quality documentation, ensuring accuracy and completeness for all products.

• Audit the receiving documentation and warehouse.

• Ensure compliance with GMP, FDA, OSHA and all other regulatory requirements, in accordance with company policy.

• Adhere to company safety requirements.

• Regular attendance as per company policy.

• Other duties as assigned.

Minimum Requirements

• High school diploma or equivalent.

• One year experience as a quality technician or experience in a similar industry/position.

• College level coursework in Chemistry or Biology preferred.

• Knowledge of chemical terminology and units of measure.

• Awareness of scientific methodology, basic statistical understanding.

• Ability to perform and understand aseptic technique in pulling some samples is required.

• Experience in a FDA regulated manufacturing environment.

• Knowledge of GMP regulations.

• Proficient with Microsoft Office, including Word and Excel.

• Ability to follow written and oral direction.

• Ability to work independently with little direction.

• Ability to read and interpret written policies and procedures.

• Ability to complete paperwork accurately.

• Good verbal communication skills.

• Ability to work with others to achieve goals.

• Excellent attention to detail.

• Ability to recognize good quality and perform to quality standards.

• Ability to work without supervision.

PHYSICAL REQUIREMENTS:

• Frequently required to talk or hear.

• Frequently required to sit, walk, and stand.

• Occasionally lift and/or move up to 50 pounds.

• Good manual dexterity.

• Ability to grasp small objects.

• Vision includes close vision, color vision and distance vision.