Take Pride in Your Work

Basic Job Functions:

Provides guidance and direction to achieve compliance with all applicable safety standards and requirements at all Accupac facilities. Inspects facilities to detect existing or potential accident and health hazards and recommends corrective or preventative measures where indicated. Oversee company-wide standard and special safety training.

Essential Functions of the Job:

• Maintains and enforces general safety policies and procedures followed by the company and personnel in compliance with state, local and federal Occupational Administration (OSHA) regulations and requirements.
• Inspect and evaluate the environment, equipment, and processes to assure safety regulations are met or exceeded.
• Oversees, maintains, or coordinates training programs or media which increase proficiency in safe practices, and promote safety consciousness.
• Ensure adherence to all SOP?s, cGMP?s and safety regulations.
• Maintain filing systems regarding worker training and safety.
• Investigate accidents to identify their causes and identify and implement preventive actions.
• Assure all assigned governmental filings are kept current. The agencies include but are not limited to the DEP, EPA, ATF, OSHA, Local Township and sewer authority.
• Ensure inspections by regulatory agencies are coordinated and deficiencies minimized and corrected.
• Coordinate with VP, Operations and Director, CI on facility deficiencies and monthly safety inspections.
• Maintain all logs and documentation associated with permits and regulatory requirements.
• Implements hazardous and environmental waste management programs to ensure compliance with contractual requirements and applicable laws, regulations and standards.
• In charge of the Employee Safety Committees.
• Ensure contractor personnel working on the property are in compliance with Accupac policies and safety requirements.
• Act as a liaison to the customer for EHS issues.
• Assist with maintaining the Site Preparedness and Emergency Plans & Procedures
• The above duties and responsibilities are representative of the nature and level of work assigned and are not necessarily all-inclusive.
• 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.

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:

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

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:

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.

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:

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.

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.

Basic Job Functions:

Responsible to assist the Team Leader in line operations that are necessary to ensure consistent flow of the packaging process and housekeeping in a safe manner. Responsible for maintaining personal safety. Responsible for communicating safety concerns to the Team Leader/Management. Able to perform all menial activities required to maintain the efficient operation of production. Is formally trained in identifying key quality requirements on product which includes cosmetic and aesthetic defects. Also able to perform quality inline inspections such as label placement and code presence. Able to assist in the purgation and cleaning of the machinery at the end of a packaging campaign. Able to perform material handling requirements and ensure that the cleanliness of the line is in control.

Essential Functions of the Job:

• Keep Capable of communicating in the English language

• Capable of reading and understand the English Language. Reference SOP QA 0029, Good Documentation Practices

• Ability to follow direction and ask questions

• Understands and abides by all gowning and un-gowning requirements.

• Abides by break time and restroom rules

• Assist in keeping assigned lines running.

• Change rolls of tape

• Communicate issues with equipment to Team Leader.

• Identify problems and communicate equipment issues which need further attention to Team Leader.

• Maintain material supply for continuous operation on assigned packaging line

• Meet area GMP and housekeeping standards

• Ability to hand place primary containers onto a conveyor belt

• Ability to hand place primary closures (Cap, Pump Caps, Plugs) onto bottles.

• Ability to assemble primary components (Vent tubes)

• Able to inspect label quality (Presence, placement, coding)

• Able to place boxes onto a skid.

• Able to build complex pallet patterns.

• Able to effectively sweep floors

• Able to secure and remove waste from the line

• Able to effectively clean conveyor belts

• Understands the proper use and redress restrictions when using the Blue, gray and red bins.

• Understands IPA usage.

• Able to understand how a counting scale works

• Able to hand carton tubes and bottles

• Able to load tubes and bottles into cartons on a cartoner

• Perform all other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

• Deeply understands and supervises all processes impacting product release and is a reference inside the organization related to the product compliance.
• Collects requirements from all stakeholders, managing trade-offs to meet product release goals.
• Improved release management framework by defining roles and responsibilities, creating templates and procedures, and implementing escalation and support frameworks.
• 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.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Adherence to customer release requirements.
• Update paper and electronic records.
• Perform 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:

The Validation Supervisor 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 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.

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:

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:

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.