Essential Responsibilities

• Maintains machinery for all production operations.
• Sustains awareness of production schedule and needs.
• Monitors production equipment to ensure a quality product.
• Complies with all procedural requirements.
• Performs troubleshooting, adjustments, and preventive maintenance of production machinery.
• Reads and interprets equipment manuals and work orders to perform required maintenance and service.
• Follows guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Identifies and implements necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Ensures compliance with GMP, FDA, OSHA, and other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for updating monthly unitized forecasts by working cross functionally with Program Management team.
• Assist Operations in the Forecast & Capacity Planning process.
• Process daily revenue and monthly large program reporting.
• Review work order entry transactions to ensure entries are accurate. Coordinate batch work order analysis and review.
• Analyze manufacturing variances on a daily, weekly and monthly basis.
• Coordinate, monitor, and maintain production order review chart.
• Routinely review overhead information and coordinate overhead rate updates.
• Review standard and actual costs for inaccuracies, update items and bills of materials.
• Prepare journal entries, account reconciliations, and month-end close processes, including WIP.
• Work with Material Review Board to locate and dispose of obsolete inventory.
• Coordinate annual physical inventory and routine cycle counts. Investigate variances and assist in resolution.
• Serve as backup for customer invoicing and process accounts receivable collections from customers.
• Provide backup for processing daily bank deposits.
• Serve as backup for payroll including processing bi-weekly paychecks, direct deposits and 401(k) transmittals.
• Function as backup for A/P including verifying and coding of invoices for payment.
• Assist with monthly spending reviews and prepare monthly cost reports of actual to budget comparisons.
• Maintain records of financial documents with supporting materials.
• Recommend, design and implement department processes and protocols.
• Perform financial analysis as requested.
• Assist VP of Finance with special projects.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, as they relate to the job position and in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Accounting or a combination of equivalent experience and education.
• 3-5 years accounting experience.
• Excellent communication skills, both verbal and written.
• 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.
• Good attention to detail.
• Good interpersonal skills.
• Good organizational skills.
• Familiarity with ERP systems (i.e. MAS 90/SAGE) preferred.
• Previous experience in a FDA-regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

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

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Document all new machine set ups.
• Sign off that set-ups performed by the Machine Set-Up Technician are complete and ready for production.
• Write troubleshooting guides.
• Maintain machinery for all production operations.
• Sustain awareness of production schedule and needs.
• Monitor production equipment to ensure a quality product.
• Comply with all procedural requirements.
• Perform troubleshooting, adjustments, and preventive maintenance of production machinery.
• Read and interpret equipment manuals and work orders to perform required maintenance and service.
• Follow guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Identify and implement necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Travel between Unicep facilities is an essential function to this position.
• Regular attendance.
• Adhere to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• 5 years’ of manufacturing/production experience.
• Associate’s degree or certificate in mechanical or industrial maintenance preferred.
• 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.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Occasionally required to sit.
• 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 provided.

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:

• Responsible for the development, administration, and communication of all company Human Resources policies and procedures, including the company policies and procedures manual, the employee handbook, and benefit summaries.
• Implement new policies and procedures as necessary and appropriate.
• Develop department goals and objectives.
• Implement and annually update the company compensation program, including establishing pay. ranges, and evaluating the merit pay program and the company incentive compensation plan.
• Manage the benefits program, including plan negotiation during annual renewal, open enrollment, ongoing monthly enrollment, compliance with all federal and state regulations, and researching and implementing new programs.
• Ensure compliance with all federal and state regulations, including FLSA, HIPAA, ERISA, OSHA, COBRA, EEO, ADA, FDA, and GMP.
• Manage the recruiting process for new employees, both exempt and non-exempt, including writing all recruitment ads and determining the most effective venue for advertising, and performing initial screening of applicants. Conduct reference checks and prior employment verification of applicants. Maintain recruiting page on the company website. Coordinate summer internship program. Represent the company at career fairs.
• Provide training on Human Resources related topics.
• Responsible for all employee relations, including employee complaints, harassment issues, ADA compliance, employee conflicts, disciplinary actions, and employee termination/exit.
• Administer company employee recognition/incentive and service awards programs.
• Manage company performance evaluation program, ensuring management compliance with review due dates. Provide monthly reports to managers of reviews due. Review and update program as necessary and appropriate.
• Create and analyze reports, including turnover, headcount, recruiting costs and timeline, overtime, benefits costs, incentive compensation, etc.
• Oversee the weekly timecard verification for hourly employees, ensuring all time to be paid is accurate.
• Participate on the company Safety Committee. 
• Administer company worker’s compensation program, including the filing of all claims, annual reporting, claims analysis, and return-to-work programs.
• Create and update all company job descriptions. Review all job descriptions biennially for accuracy and compliance with the FLSA, ADA, and GMP, and to evaluate compensation ranges.
• Maintain company organization chart.
• Supervise Human Resources Coordinator.
• Regular attendance.
• Adhere to company safety requirements.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Business Administration or a related field, or an equivalent combination of education and experience.
• 5 years of progressive Human Resources experience.
• Professional in Human Resources (PHR), SHRM-CP or SHRM-SCP designation 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, Excel, and Power Point.
• Experience in Sage preferred.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established timelines.
• Excellent attention to detail.
• Excellent interpersonal skills.
• Good organizational skills.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Ability to travel by car to support multiple facilities and/or recruiting efforts.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Occasionally required to bend at waist.
• Frequently required to lift and/or move up to 25 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

• 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.