Take Pride in Your Work

Basic Job Functions:

The Project Manager is responsible to ensure that Accupac, Inc. is providing its

Customers with the best possible service in meeting their contract manufacturing and packaging needs. They must work with their Customers and the other areas of the company to see projects are completed on time, with the correct quantity, and within Customer specifications. This position is also responsible to be the main communications link between the Customer and Accupac. Finally, the Project Manager is responsible for higher level planning and management of new Projects at Accupac.

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Essential Functions of the Job:

1. Must have detailed knowledge of all aspects of their Customer?s business.
2. Maintain Follow-Up files on all Customer Service issues relating to their customers.
3. Administer all systems aspects of their Customer?s projects including entering of Sales Orders, Part Numbers, Bills of Materials, Formula, Pricing, etc.
4. Communicate Customer requirements to the rest of the organization via email, written communication, and pre, prior, and post production meetings.
5. Keep the Manager of Customer Support up to date on progress of their accounts.
6. Issue a bi-weekly summary report to their Customers outlining the status of their orders.
7. Follow-up on all materials needed to produce their Customer?s orders to support Production.
8. Control Customer projects from order origination to final approval and shipment per Customer specifications.
9. Communicate Customer priorities to the Scheduling Group.
10. Work with Quality Assurance Group to ensure products are being made to Customer specification.
11. Direct Materials Group in dispositioning excess and obsolete materials.
12. Report monthly on orders completed, non conformances, materials not on B.O.M. or S.O., QA issues, visitors, customer specialty data, accomplishments and initiatives.
13. Report at weekly Project Summary Meeting on status of their accounts.
14. Maintenance of Customer files.
15. Research and solve Customer Service problems, proactively initiate assistance, when necessary, and track progress until final resolution is achieved.
16. Evaluate, initiate and conduct and follow-up on meetings with Customers and within Accupac.
17. Develop and distribute Job Orders describing Customer projects for the rest of the organization.
18. Make sure that all inventory, quality and procedural requirements for production have been met the Wednesday before production.
19. Conduct Conference Calls with Customers, summarize, and follow-up.
20. The Project Manager should exercise good judgment in resolving issues which arise as a part of day to day interaction with internal and external customers.
21. Responsible for maintaining Accupac?s meeting of Customer measurements.
22. Perform other duties as assigned.

Job Summary:

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The Manager, Lab Services position is responsible for managing all activities associated with the daily operation of the Quality Assurance Analytical Laboratory. This includes training, evaluating and directing laboratory staff, reviewing and implementing customer?s test methods, implementing new technology, investigating and resolving technical problems and investigations, and prioritizing the laboratory schedule in a way that meets the needs of the Manufacturing, Production and Customer Service departments.

The Manager also participates in quality related activities outside of the laboratory, and is the primary interface between the laboratory and other departments.

Essential Duties and Responsibilities include but are not limited to the following:

1. Assure that testing priorities support Manufacturing, Production and Customer Service schedules.

2. Ensure final data is complete and properly documented.

3. Follow up and communicate status of ?hot? items, problems and schedule changes.

4. Develop contingency plans to avoid missing schedule expectations.

5. Assure adequate communication of priorities exists between the lab and other departments and within the lab from shift to shift.

6. Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.

7. Maintain knowledge of customer?s specifications and testing procedures.

8. Assure that all raw materials, bulks, and finished goods are tested in accordance with customer requirements.

9. Assure test failures are investigated and documented, and that corrective action is taken, by working with the Investigation Specialist.

10. Prepare justification for new lab equipment.Prepare purchase orders and coordinate authorization and procurement.Arrange installation and qualification.

11. Evaluate new test methods.Coordinate implementation of new methods.

12. Resolve test method problems which involve interaction with customer?s technical staff.Respond to technical questions from customers about laboratory issues.

13. Evaluate time and cost aspects of laboratory work associated with new products or new testing requirements.

14. Provide analytical technical support to validation projects.

15. Assist in solving Manufacturing and Production problems.

16. Assure calibrations, standards, log books and other GMP compliance activities are performed in the laboratory.

17. Develop and implement ways to improve laboratory productivity, cost control and output.

18. Review and approved SOP?s, specifications, and other documentation required to administer the laboratory.

19. Perform other duties as assigned.

Basic Job Functions:

Perform sampling and inspection of packaging components using standard inspection techniques and methodology. Sample raw materials and bulks to specific amounts that conform to the customer?s specification in a manner that complies with Accupac?s Standard Operating Procedures and the FDA?s Good Manufacturing Practice regulations.

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Essential Functions of the Job:

1. Perform functional and aesthetic inspection on incoming packaging components per approved Accupac SOPs, and customer specifications.

2. Advice the QA Incoming Supervisor/QA Management of non-conforming components found during incoming inspection.

3. Create, review and approve component Material Assay Reports.Revise as necessary.

4. Read, comprehend and interpret written instructions in order to obtain raw materials in quantities that conform to customer specifications.

5. Identify raw material sampling issues when they arise and notify QA Incoming Supervisor and/or QA appropriate personnel of such issues.

6. Clean and maintain the raw material sampling suites according to established housekeeping procedures.

7. Review and understand Standard Operating Procedures

8. Organize and maintain QA document storage areas

9. Maintain raw material and finished goods reserve sample storage area.

10. Ensure that measuring devices used for incoming inspections are calibrated according to established Standard Operating Procedures.

11. Support the stability program by setting up materials in the stability chambers and pulling samples from the stability chambers at predefined times as defined by an approved stability protocol.

12. Assist with temperature and humidity monitoring of stability chambers and specified warehouse locations.

13. Assist with Sampling/Inspection training.

14. Interact with the Project Management and Purchasing groups to keep them apprised of issues that arise during incoming component inspections and raw material sampling.

15. Perform other duties as assigned.

Basic Job Functions

Provide support to Quality Systems (review SOPs, protocols, reports, data, records generated and other quality-related documents) for the manufacturing and distribution of product.

Essential Functions of the Job

1. Investigate complaints received at Accupac
2. Triage complaint notifications
3. Compile data/documentation from Manufacturing, Packaging, and/or Laboratories.
4. Determine conclusions, prepare investigation reports and assign relative CAPAs
5. Participate in analytical laboratory investigations (LIR) and other non-conformance investigations (NIR)
6. Gather critical data and review in LIMS
7. Gather critical data and enter onto spreadsheets
8. Conduct personnel interviews and system reviews
9. Observe analytical testing for investigations
10. Prepare investigation reports and oversee applicable approvals
11. Communicate with customers, project managers and Management
12. Assure timely closure of CAPAs, assist in performing effectiveness checks
13. Reviews records to ensure data meets the industry requirements for data integrity - resolve any discrepancies
14. Ensure procedures are followed as outlined per FDA, ICH, Standard Methods and the Quality Systems? requirements
15. Support Management with audits.
16. Perform other quality-related duties as assigned.

Basic Job Functions:

Responsible to perform activities necessary to maintain and operate the chemical analysis laboratory during assigned Shift. Responsible to carry out technical tasks and support production operations; perform routine and non-routine chemical testing of raw materials, bulk products finished goods, environmental samples and validation samples; and evaluate and implement new chemical analysis procedures.

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Essential Functions of the Job:

1. Resolve problems with instruments, test methods, lab chemicals, standards, and samples with direct support from Management.

2. Assure calibrations, standards, log books and other GMP compliance activities are performed in the laboratory.

3. Perform in-process, routine and non-routine chemical testing of raw materials, bulk products, finished goods, environmental samples and validation samples using approved procedures.

4. Maintain notebooks, assay reports, log books and other documentation in accordance with cGMP.

5. Sample materials, bulks and finished goods.

6. Perform other duties as assigned.

Basic Job Functions

Provide support to Quality Systems (review SOPs, protocols, reports, data, records generated and other quality-related documents) for the manufacturing and distribution of product.

Essential Functions of the Job

1. Investigate complaints received at Accupac
2. Triage complaint notifications
3. Compile data/documentation from Manufacturing, Packaging, and/or Laboratories.
4. Determine conclusions, prepare investigation reports and assign relative CAPAs
5. Participate in analytical laboratory investigations (LIR) and other non-conformance investigations (NIR)
6. Gather critical data and review in LIMS
7. Gather critical data and enter onto spreadsheets
8. Conduct personnel interviews and system reviews
9. Observe analytical testing for investigations
10. Prepare investigation reports and oversee applicable approvals
11. Communicate with customers, project managers and Management
12. Assure timely closure of CAPAs, assist in performing effectiveness checks
13. Reviews records to ensure data meets the industry requirements for data integrity - resolve any discrepancies
14. Ensure procedures are followed as outlined per FDA, ICH, Standard Methods and the Quality Systems? requirements
15. Support Management with audits.
16. Perform other quality-related duties as assigned.

Basic Job Functions:

Applies electrical/electronic theory, personal experience and related knowledge to support facility and production requirements. Responsible for installing, monitoring and maintaining the plants power distribution system. Responsible to build, test, troubleshoot, repair and/or modify electronic/electrical controls. Required to assist mechanics in troubleshooting and repairing production equipment.

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Essential Functions of the Job:

• Use deductive reasoning to understand problems, determine cause and affect repairs.

• Must be familiar with and able to troubleshoot 110/208 volt Single phase; 208-460 volt 3 phase. Prefer DC voltage experience.

• Troubleshoot and repair electrical controls for facility and production equipment.

• Install, maintain and repair electrical equipment used in the plant

• Read, comprehend and interpret electrical and mechanical prints, operating manuals, parts lists and specifications.

• Communicate with mechanics and non-technical people to determine and resolve issues

• Make standard computations relating to lad and sizing requirements for wiring electrical equipment

• Make required repairs in a timely and cost effective manner

• Order repair parts, as needed, and recommend changes to the inventory of spare parts and special tool inventory.

• Conduct and document calibrations performed on assigned equipment.

• Follow all applicable SOP?s and cGMP?s, safety guidelines, published regulations and appropriate codes.

• Work closely with the engineering group to control and document all changes.

• Support and participate in engineering projects.

• Work as directed on special projects and assignments dictated by customer and/or schedule requirements.

• Perform all other duties as assigned.

Basic Job Functions:

Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.

Essential Functions of the Job:

• Manage the Annual Drug Product Review (ADPR) process.
• Support the Change Control process including initiation, approvals, and closure.
• Initiate and participate in investigations (including Laboratory Investigations).
• Manage the CAPA process including initiation, closure and performance of Effectiveness Checks.
• Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
• Perform Production line inspections.
• Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment.
• Perform daily checks of temperature monitoring units and notification to management/facilities of excursions.
• Reconcile staged components with approved bill of materials.
• Sample, inspect, and approve customer and vendor components.
• Sample, identify, and submit customer and vendor raw materials to the lab for testing.
• Perform all required testing at established frequency.
• Record all test and inspection results immediately and accurately.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Draft, review and approve component MARS, manufacturing batch records, and packaging batch records.
• Review and approve batch records for release of customer product.
• Resolve any documentation discrepancies related to assigned tasks.
• Update paper and electronic records.
• File and archive documentation.
• Perform other duties as assigned.

Basic Job Functions:

Performs mechanical set ups and maintenance tasks on assigned production lines to ensure its smooth operation. Is knowledgeable on each individual component of a production line and the correct set up for interaction and connection between them for maximum efficiency. Performs preventative maintenance and participates in training programs, as required.

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Essential Functions of the Job:

• Packaging Mechanic level and compensation will be determined by successful completion and verification of levels in the Packaging Mechanic Skill Level Chart.
• Set up full line configurations of multiple pieces of equipment, independently
• Supervise subordinate mechanical personnel and assist in trouble shooting and training
• Generate Purchase Requisitions for materials and parts needed
• Interact with Management to assist in new project quotation generation by providing input on equipment choices, potential capital purchases or improvements and estimated output.
• Other Duties:
  • Performs other related duties as required and assigned.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

Basic Job Functions:

Performs mechanical set ups and maintenance tasks on assigned production lines to ensure its smooth operation. Is knowledgeable on each individual component of a production line and the correct set up for interaction and connection between them for maximum efficiency. Performs preventative maintenance and participates in training programs, as required.

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Essential Functions of the Job:

• Packaging Mechanic level and compensation will be determined by successful completion and verification of levels in the Packaging Mechanic Skill Level Chart.
• Set up full line configurations of multiple pieces of equipment, independently
• Supervise subordinate mechanical personnel and assist in trouble shooting and training
• Generate Purchase Requisitions for materials and parts needed
• Interact with Management to assist in new project quotation generation by providing input on equipment choices, potential capital purchases or improvements and estimated output.
• Other Duties:
  • Performs other related duties as required and assigned.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

Basic Job Functions:

Applies electrical/electronic theory, personal experience and related knowledge to support facility and production requirements. Responsible for installing, monitoring and maintaining the plants power distribution system. Responsible to build, test, troubleshoot, repair and/or modify electronic/electrical controls. Required to assist mechanics in troubleshooting and repairing production equipment.

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Essential Functions of the Job:

• Use deductive reasoning to understand problems, determine cause and affect repairs.

• Must be familiar with and able to troubleshoot 110/208 volt Single phase; 208-460 volt 3 phase. Prefer DC voltage experience.

• Troubleshoot and repair electrical controls for facility and production equipment.

• Install, maintain and repair electrical equipment used in the plant

• Read, comprehend and interpret electrical and mechanical prints, operating manuals, parts lists and specifications.

• Communicate with mechanics and non-technical people to determine and resolve issues

• Make standard computations relating to lad and sizing requirements for wiring electrical equipment

• Make required repairs in a timely and cost effective manner

• Order repair parts, as needed, and recommend changes to the inventory of spare parts and special tool inventory.

• Conduct and document calibrations performed on assigned equipment.

• Follow all applicable SOP?s and cGMP?s, safety guidelines, published regulations and appropriate codes.

• Work closely with the engineering group to control and document all changes.

• Support and participate in engineering projects.

• Work as directed on special projects and assignments dictated by customer and/or schedule requirements.

• Perform all other duties as assigned.

Basic Job Functions:

The Compounder is responsible for manufacturing a customer?s product by following a set of written instructions. This activity involves the interpretation and execution of written instructions that results in a bulk product that conforms to the customer?s specifications. The Manufacturing operation is performed in a manner that complies with Accupac?s SOP and the FDA?s Good Manufacturing Practices Regulations.

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Essential Functions of the Job:

• Compounder level and compensation will be determined by successful completion and verification of levels in the Compounder Skill Level Chart.

• Clean and sanitize manufacturing related equipment and utensils.

• Set-up manufacturing equipment to support a specific manufacturing operation.

• Scan all labor activities into the central computer system.

• Document all relative activities associated to the batch in respective equipment logbooks.

• Verify that the manufacturing equipment is suitable for its intended use and that it has been cleaned & sanitized.

• Verify that the information on the raw material Barcode Tickets and the manufacturing batch card are in agreement and have not expired.

• Advise direct supervisor of any raw material information nonconformance and set the material aside for final disposition.

• Follow the customer?s written instructions.Advise the immediate supervisor of all process deviations.

• Advise the Quality Assurance Group when they can sample the completed bulk product.

• Prepare bulk storage tanks for new product receipts.Participate in the unloading process of the receipt.

• Perform the daily monitoring of manufacturing systems.

• Provide the Quality Assurance Laboratory with routine DI Water samples.

• Perform minor preventative maintenance tasks on the equipment.

• Perform the scheduled / routine cleaning and painting of the manufacturing area and equipment.

• Interface promptly and courteously with all Accupac, Inc. employees and visitors.

• Perform all jobs in a safe and efficient manner.

• Perform all other duties as assigned.

Basic Job Functions:

Responsible to perform activities necessary to maintain and operate the chemical analysis laboratory during assigned Shift. Responsible to carry out technical tasks and support production operations; perform routine and non-routine chemical testing of raw materials, bulk products finished goods, environmental samples and validation samples; and evaluate and implement new chemical analysis procedures.

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Essential Functions of the Job:

1. Resolve problems with instruments, test methods, lab chemicals, standards, and samples with direct support from Management.

2. Assure calibrations, standards, log books and other GMP compliance activities are performed in the laboratory.

3. Perform in-process, routine and non-routine chemical testing of raw materials, bulk products, finished goods, environmental samples and validation samples using approved procedures.

4. Maintain notebooks, assay reports, log books and other documentation in accordance with cGMP.

5. Sample materials, bulks and finished goods.

6. Perform other duties as assigned.

Basic Job Functions:

Responsible for the safe and successful operation of assigned production lines in compliance with quality standards, Good Manufacturing Practices, company SOP?s and corporate policy while maintaining established production quotas.

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Essential Functions of the Job:

• Team Leader level and compensation will be determined by successful completion and verification of levels in the Team Leader Skill Level Chart.
• Report to work at least 45 minutes prior to the start of the scheduled shift.
• Follow line check-in procedures as specified in SOP?s # QA0012 and PK0008.
• Verify that the correct batch code is being printed on product by checking product drums or tanks supplying the line.
• Verify that the package being produced is accurate according to customer specifications.
• Assist the Packaging Supervisor in packaging line audits as needed.
• Ensure that waste is kept within acceptable limits, offering suggestions for waste reduction, when possible.
• Ensure that all assigned Line Workers and Material Handlers are working efficiently and safely.
• Ensure that materials are being handled in compliance with Good Manufacturing Practices, SOP?s and current company policies.
• Operate production lines so to achieve or exceed production standards for the output per man-hour and per line-hour.
• Adjust machinery as necessary within parameters of training/ability.
• Complete and affix Finished Goods tickets to pallets.
• Complete and submit all required production documentation in compliance with cGMP and verify accuracy of all information.
• Apprise Packaging Supervisor of relevant information regarding employee performance, machinery, safety and quality
• Monitor the state of other packaging lines as needed.
• Interact with customers who are in attendance for line tests and new product start-ups.
• Perform all other duties as assigned.

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