Take Pride in Your Work

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:

• Perform functional and aesthetic inspection on incoming packaging components per approved Accupac SOPs, and customer specifications.
• Advice the QA Incoming Supervisor/QA Management of non-conforming components found during incoming inspection.
• Create, review and approve component Material Assay Reports. Revise as necessary.
• Read, comprehend and interpret written instructions in order to obtain raw materials in quantities that conform to customer specifications.
• Identify raw material sampling issues when they arise and notify QA Incoming Supervisor and/or QA appropriate personnel of such issues.
• Clean and maintain the raw material sampling suites according to established housekeeping procedures.
• Review and understand Standard Operating Procedures
• Organize and maintain QA document storage areas
• Maintain raw material and finished goods reserve sample storage area.
• Ensure that measuring devices used for incoming inspections are calibrated according to established Standard Operating Procedures.
• 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.
• Assist with temperature and humidity monitoring of stability chambers and specified warehouse locations.
• Assist with Sampling/Inspection training.
• Interact with the Project Management and Purchasing groups to keep them apprised of issues that arise during incoming component inspections and raw material sampling.
• Perform other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

• Prepare, issue, scan, and file quality documents.
• Manage the document life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
• Ensure quality documents accurately reflect current procedure.
• Translation of customer specifications into Accupac documentation.
• Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
• Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
• File and archive documentation.
• Perform other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

• Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
• All production control records have been compiled and are complete and accurate.
• All Laboratory Services release testing showed satisfactory conformance to bulk and finished product specifications.
• Execute or coordinate the resolution to excursions identified during the batch review process.
• Issue and perform review of logbooks and notebooks.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Adherence to customer release requirements.
• Update paper and electronic records.
• File and archive documentation.
• Perform other duties as assigned.

Basic Job Functions:

The Senior Validation Specialist must have a working knowledge and clear understanding of all validation activities. S/he will plan and schedule validation projects, including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGMP requirements.

S/he is responsible for reviewing customer supplied documentation, assess what validation activities are required as per Accupac Validation Master Plan and review the information with the Quality Systems[PC1] Team. In addition, the Sr. Quality Validation Specialist will write the validation protocols, lead in the execution of the protocols, and write the Validation Report.

Essential Functions of the Job:

• Hands-on experience in Equipment and Facility Validation and / or Qualification in GMP environment. This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
• Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.
• Review of validation documentation associated with all validation activities, PM, and calibration to ensure completeness, accuracy, cGMP compliance, data acceptability and conformance to FDA procedures and requirements.
• Carry out validation activities of equipment and systems IQ, OQ, PQ’s to maintain compliance in all manufacturing areas and complete validation reports and resolution of deviations.
• Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
• Coordinate successful execution of projects by working effectively with internal/customer cross functional.
• May interface with the FDA and customers during site audits to respond to validation-related questions.
• May be involved in investigations and root cause analysis for incidents reported on validated systems.
• Maintain Calibration Management database e.g. enter, change, and update equipment status.
• Provide oversight on the timely completion of PMs and Calibrations and send equipment off site for calibrations and/or PMs as needed.
• Performs other related duties as required and assigned.

Basic Job Functions:

Responsible to perform the physical unloading, loading, transfer, storage, shipping, physical handling and movement of all materials throughout Accupac’s warehouse facilities.

Essential Functions of the Job:

1. Warehouse Staff level and compensation will be determined by successful completion and verification of levels in the Warehouse Skill Level Chart.

2. Load and unload trucks/trailers

3. Prepare materials for proper identification, sampling and warehouse storage.

4. Bar Code ticketing of all materials as per established procedures.

5. Verify and sign delivering carrier’s Bills of Lading.

6. Locate and transfer materials between the warehouse, manufacturing and production areas.

7. Verify, count and inventory materials.

8. Accurately report material locations through the effective use of the Bar Code Inventory System. Includes efficient use of Intermec PC unit.

9. Proper daily maintenance and care of all warehouse materials handling equipment.

10. Maintain constant good housekeeping and cleanliness in accordance with all cGMP and FDA regulations.Adhere to all Department and Company SOP’s.

11. Accurately complete all Receiving Reports, Trailer Inspection Forms, Inter-company Transfer Sheets, Finished Goods Audit Lists, and distribute paperwork accordingly.

12. Effectively verify and load outbound trailers (common carrier, contract, air freight).

13. Stretch wrap pallets of raw materials, packaging components and finished goods.

14. Comply with all safety rules and regulations.

15. Accurately enter receiving reports into Accuterm.

Basic Job Functions:

The Sr. Manager of QS position is responsible for guiding and monitoring the development and application of systems and practices, which support Accupac?s quality mission. This position is central to the establishment, review, and authorization and auditing of policies and procedures, documentation systems, training programs, and other elements of Good Manufacturing Practice. The position serves as a contact for quality and regulatory issues, and for compliance audits. The position is also responsible for management of the QS in a way that meets current business needs and prepares for the Company?s growth and expanded QS responsibilities.

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Essential Functions of the Job:

• Define, justify, and implement the Quality Systems staffing requirements.
• Assure QS employees understand their jobs and what is expected of them.
• Responsible for development and performance of the team and provide counseling as needed.
• Prepare and administer employee?s annual performance reviews.
• Assure that the QS strategy and priorities are consistent with business needs and are communicated to the team.
• Monitor the Department?s productivity and work with the team to develop ways to improve it.
• Assure QS employees receive timely communication of business issues, and that two-way communication channels remain open between employees and management.
• Assure that QS employees have adequate resources to perform their jobs.
• Prepare and manage the Department?s budget and monitor expenses.
• Develop and enhance billable activities to increase business revenues.
• Review new business proposals to identify and resolve QS issues.
• Confer with customer?s representatives to obtain information related to customer?s quality standards.
• Assure all Feedback from customers is addressed, communicated and documented.
• Assure documentation and maintenance of records pertaining to product quality.
• Assure that Out-Of-Specification results, process deviations, and other Quality Events are investigated and documented.
• Support customer compliance audits, validations, and other quality events.
• Serve as liaison during inspections by customers and regulatory agencies.
• Assure that Accupac?s validation program maintains an acceptable level of technical quality.
• Review and approve Master SOP?s, Material Assay Reports, Batch Cards and other documents.
• Review and approve Batch Record, Specification, and customer?s documents.
• Assist in preparation of the Quarterly Quality Assurance Department report.
• Annually receive formal (i.e.: seminar, class,) or informal (trade journals, FDA 483 review) training, industry best practices and FDA regulations
• Perform other duties as assigned.

Basic Job Functions:

The Support Analyst is responsible for performing tasks involving the proper acquisition, installation, management and troubleshooting of Accupac?s infrastructure equipment, including but not limited to personal computers, printers, barcode scanners, routers and network switches. This position is the first contact for most end-user computer issues and is expected provide Tier I and II level computer support. This position will also be expected to support basic problems and perform routine maintenance with the Accuterm ERP/MRP system, as well as the related systems that support the mainframe, such as SQL server and Weblogic server.

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Essential Functions of the Job:

1. Responding to help desk requests in a timely fashion, escalating issues to senior techs as needed
2. Documenting all communication and tasks performed including closing out help desk requests when completed
3. Keeping the team informed of current issues
4. Manage all hardware equipment and related documentation
5. Maintain, order and manage peripheral equipment and supplies for PC?s and Barcode equipment
6. Install hardware, cabling, and configure software needed to connect PCs to the network
7. Perform Installation Qualifications documenting hardware and software installation
8. Perform and/or coordinate the repair of PC, barcode and related hardware
9. Manage equipment relocation, setup and related connections
10. Working with vendor technical support as needed
11. Communicating project plan to appropriate staff and department managers as well as outlining any end user process changes
12. Building imaging and maintaining desktops, laptops and virtual machines
13. Researching, testing and installing of internal software
14. Configuring and supporting mobile devices as needed
15. Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
16. Assisting in establishing and enforcing departmental standards
17. Participating in the modification of company SOPs related to Information Technology
18. Creating and maintaining departmental work instructions
19. Ensure proper operation and availability of local area network through the performance of day-to-day maintenance and monitoring.
20. Perform daily backup procedure and verify procedural integrity to minimize data loss in the event of system catastrophes or accidental deletions.
21. Troubleshoot and solve internal user problems concerning PC?s, Network, Exchange, Intranet and related peripherals.
22. Install and support PC and network related software as well as provide training and documentation to end users for PC hardware and software.
23. Provide help desk support for all IS relevant hardware and software
24. 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.

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 managing the care and maintenance of all Accupac Facility assets and grounds. Fundamental knowledge of facility related equipment and processes. Well organized and self- motivated. Ability to delegate and manage facility-related activities, identify opportunities, and implement solutions. Must always maintain appearance of facilities to inspection ready levels.

Responsible for managing 15-20 employees within the facilities department including temporary employees.

Responsible for maintaining a safe work environment and eliminate safety hazards throughout the facilities.

Essential Functions of the Job:

• Enforce all company policies and procedures, including: SOP’s/GMP’s/OSHA and Safety Compliance.
• Ability to interpret and apply basic principles of engineering.
• Maintain the Preventative Maintenance Program and monitor performance.
• Provide, manage, and coordinate internal and external maintenance support for all departments within the facilities.
• Assist with annual capital planning.
• Establish Departmental Standards and Goals, and track attainment.
• Assist with the generation and review of all IQOQs that support equipment installations.
• Responsible for managing all facilities related activities. This includes, but is not limited to:
• Manage PM program
• Coordinate service calls
• Electrical Distribution/Systems
• Manage house and grounds for all seasons
• Manage annual contracts with contractors and vendors on an annual basis
• Alarm systems
• Manage system failures
• Coordinate annual inspections
• Sprinkler and fire suppression systems (including extinguishers)
• Responsible for managing required PMs and emergency service for facility related equipment including but not limited to:
• HVAC Systems
• Boilers
• Air compressors
• Dryers
• Chillers
• Wastewater System
• Emergency safety warning systems
• Facility structures
• Manages wastewater treatment system and ensures filings and reporting’s are current.
• Ensure all regulatory filings are kept current. The agencies include but are not limited to:
• DEP
• EPA
• ATF
• OSHA
• Local Township
• Evaluate performance of assigned personnel and conduct periodic reviews.
• Participate in accident investigations and preventative measures when applicable.
• Provide employee development and training as required.
• Projects, special assignments, and travel as required.
• Modifies applicable SOPs and processes as required.
• Provides response to internal and external customer concerns and findings. Tracks CAPA’s.
• Perform all 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.

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.

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:

Responsible to clean and sanitize production line filling hoppers and auxiliary equipment to prevent product contamination during the packaging process following Standard Operating Procedures in compliance with cGMP's and safety regulations. To receive training and gain familiarity in the operation and composition of packaging equipment in order to qualify for advancement.

Essential Functions of the Job:

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

2. Dismantle and properly reassemble hoppers, pumps and buffer tanks removing auger from hopper and “O” rings from pumps.

3. Clean and sanitize machinery inside and outside including hopper, pumps and buffer tanks by applying hot water, Purified-water and alcohol with rags and brushes using pressure on the machinery to remove accumulated product and impurities.

4. Inspect all disassembled parts, for wear and replace/order spare parts for inventory, as necessary.

5. Clean up work area removing and storing cleaning utensils and solvents and disposing of soiled/used cleaners.

6. Perform Preventive maintenance on equipment they have been trained on and properly document in all Log Books upon completion of tasks.

7. Refill hopper with bulk product and slide up to 55 gallon drum full of material into position on the packaging line for automatic fill of conveyor belt product containers.

8. Perform all jobs in a safe and efficient manner.

9. 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.

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:

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.

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 the physical unloading, loading, transfer, storage, shipping, physical handling and movement of all materials throughout Accupac’s warehouse facilities.

Essential Functions of the Job:

1. Warehouse Staff level and compensation will be determined by successful completion and verification of levels in the Warehouse Skill Level Chart.

2. Load and unload trucks/trailers

3. Prepare materials for proper identification, sampling and warehouse storage.

4. Bar Code ticketing of all materials as per established procedures.

5. Verify and sign delivering carrier’s Bills of Lading.

6. Locate and transfer materials between the warehouse, manufacturing and production areas.

7. Verify, count and inventory materials.

8. Accurately report material locations through the effective use of the Bar Code Inventory System. Includes efficient use of Intermec PC unit.

9. Proper daily maintenance and care of all warehouse materials handling equipment.

10. Maintain constant good housekeeping and cleanliness in accordance with all cGMP and FDA regulations.Adhere to all Department and Company SOP’s.

11. Accurately complete all Receiving Reports, Trailer Inspection Forms, Inter-company Transfer Sheets, Finished Goods Audit Lists, and distribute paperwork accordingly.

12. Effectively verify and load outbound trailers (common carrier, contract, air freight).

13. Stretch wrap pallets of raw materials, packaging components and finished goods.

14. Comply with all safety rules and regulations.

15. Accurately enter receiving reports into Accuterm.