Take Pride in Your Work

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:

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:

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:

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.