Take Pride in Your Work

Basic Job Functions:

The Human Resources Director is responsible to ensure that Accupac is in compliance with all governmental regulations pertaining to employment, unemployment and workers compensation. Of equal importance, is the responsibility to ensure that Accupac maintains good relations with its employees through benefits administration, policies, procedures, communication, etc.

Essential Functions of the Job:

• Oversee all aspects of human resources, its practices and operations, both tactical and strategic.
• Manage the members of the Human Resources team.
• This position will report to and collaborate with the President on strategic matters and HR initiatives.
• Build strong relationships with Accupac’s business leaders; learn all aspects of their departments to better serve them as a business partner. Serve as a member of the Accupac executive team.
• Develop, implement, communicate and enforce all HR policies and procedures.
• Ensure strong delivery of HR programs and services including Benefits, Recruitment/Staffing, Compensation, Compliance, Employee Relations, Employee Engagement, Recognition & Rewards and Development & Training.
• Identify ineffective workflows, structures, and systems, and redesign them to fit current business needs; develop plans to implement changes to achieve better results throughout the organization.
• Work with the Talent Acquisition Specialist to support the organization’s talent acquisition efforts for both executive and non-executive positions. This position plays a critical role in ensuring that Accupac acquires and retains the best possible talent. Strong talent assessment skills are required.
• Conduct confidential investigations into employee relations matters in a fair and consistent manner; ensure that Accupac’s progressive discipline guidelines are followed and recommend solutions to complex employee relations problems.
• Manage all required compliance. Provide perspective on legal/regulatory/labor law issues which impact the organization.
• Develop and drive diversity initiatives.
• Create focus on retention and engagement of talent.
• Balance the needs of the company with the needs of each employee.
• Collaborate with leadership team to build a culture of respect and inclusiveness.
• Gain and maintain organizational trust through competent, open, and consistent actions and communications.
• Serve as advisor to Fun, Fun, Fun Committee.
• Perform other duties as assigned or required.

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:

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

Essential Functions of the Job:

1. Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.

2. Perform Production line inspections.

3. Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment.

4. Perform daily checks of temperature monitoring units and notification to management/facilities of excursions.

5. Reconcile staged components with approved bill of materials.

6. Sample, inspect, and approve customer and vendor components.

7. Sample, identify, and submit customer and vendor raw materials to the lab for testing.

8. Perform all required testing at established frequency.

9. Record all test and inspection results immediately and accurately.

10. Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.

11. Initiate and participate in investigations and CAPAs.

12. Draft, review and approve component MARS, manufacturing batch records, and packaging batch records.

13. Review and approve batch records for release of customer product.

14. Resolve any documentation discrepancies related to assigned tasks.

15. Update paper and electronic records.

16. File and archive documentation.

    Perform other duties as assigned.

Basic Job Functions:

Responsible to perform routine microbiological testing of raw materials, bulks and finished products per customer supplied or compendia test methods.

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Essential Functions of the Job:

• Associate Microbiologist I & II:
• Perform routine laboratory tasks based on current standard operating procedures.
• Maintain neat and accurate documentation in logbooks, assay reports and protocols in acceptance with current GMP requirements.
• Prepare and sterilize media.
• Perform growth promotion and sterility testing of media prepared and purchased, including quantification and evaluation.
• Perform swab sampling on sanitized equipment.
• Perform viable environmental sampling of facilities.
• Maintain inventory of lab supplies.
• Safe handling of viable pathogenic bacteria strains including Gram staining and identification.
• Understanding of proper aseptic technique and processes.
• Perform other duties as assigned.
• Associate Microbiologist II:
• Train new personnel in customer and compendia test methods.
• Interact as liaison with outside departments.
• Cover for Lab supervisor.
• Hold shift change meetings to communicate relevant information of the day.
• Involvement in the Plant Hygiene Program.
• Perform other duties as assigned.

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Basic Job Functions:

Responsible primarily for all facility housekeeping duties internally and externally as directed.

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Essential Functions of the Job:

• Perform internal facilities housekeeping duties including but not limited to, the collection of trash and cardboard, the mopping of floors, vacuuming, washing, windows/blinds, dusting, buffing, shampooing carpets, cleaning bathrooms/break areas, and care for internal plants.
• Perform general external facilities maintenance duties, including but not limited to, yard work, policing of the parking lot, removal of snow and ice as needed.
• Assist in moving and relocation of personnel as required.
• Recommend safety considerations to Facilities Supervisor.
• Respond to all building housekeeping requests in a timely fashion.
• Maintain a neat and orderly work area.
• Perform other duties as directed by the Manager.

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:

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:

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 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 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:

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 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:

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:

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 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

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.