Take Pride in Your Work

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

• Participate in analytical laboratory investigations (LIR) and other non-conformance investigations (NIR)
• Gather and analyze critical data from Lab Services (raw data, chromatography, calculations, data trend study) and review in LIMS
• Review Test methods and Laboratory notebooks for accuracy
• Analyze instrument performance, column age, previous failures
• Gather critical data and enter onto spreadsheets
• Conduct personnel interviews and system reviews
• Observe analytical testing for investigations
• Prepare investigation reports and oversee applicable approvals
• Compile data/documentation from Manufacturing, Packaging, and/or Laboratories
• Determine conclusions, prepare investigation reports and assign relative CAPAs
• Summarize and complete the LIR with a scientific assignable root cause and update the LIR spread sheets in a timely manner
• Communicate effectively with customers, project managers and Lab Management
• Assure timely closure of LIRs, CAPAs, assist in performing effectiveness checks
• Review records to ensure data meets the industry requirements for data integrity - resolve any discrepancies
• Ensure procedures are followed as outlined per FDA, ICH, Standard Methods, SOP and the Quality Systems? requirements
• Support Management with audits.
• Perform other quality-related duties as assigned.
• Maintain and Publish Monthly metrics on Laboratory investigation

Basic Job Functions:

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

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Essential Functions of the Job:

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

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Basic Job Functions

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

Essential Functions of the Job

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

Basic Job Functions:

Responsible 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.

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Basic Job Functions:

To sell contract manufacturing services to major OTC and Personal Care companies throughout the United States. To educate industries on contract manufacturing and packaging services and solutions offered by Accupac, Inc.

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Essential Functions of the Job:

1. Must compile lists of prospective customers for use as sales leads, based on information from retail stores, business directories, industry ads, trade shows, Internet Web sites, social media and other sources.

2. Travels throughout assigned territory to call on regular and prospective customers to solicit orders, or talks with customers via email or by phone.

3. Displays or demonstrates services, using samples or presentations.

4. Quotes prices and credit terms and prepares sales contracts for orders obtained.

5. Estimates date of delivery to customer, based on knowledge of own firm's production and delivery schedules.

6. Prepares reports of business transactions and keeps expense accounts.

7. Writes detailed reports of customer visits and other communication.

8. Present current and relevant market data.

9. Works with project managers to keep account activities up to date.

10. Tracks stock levels.

11. Coordinates customer training.

12. Enters new customer data and other sales data for current customers into computer database.

13. Develops and maintains relationships with a variety of contacts.Including, purchasing, package development, R&D and marketing.

14. Investigates and resolves customer problems with deliveries.

15. Attends trade shows.

16. Perform other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

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

• Clean and sanitize manufacturing related equipment and utensils.

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

• Scan all labor activities into the central computer system.

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

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

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

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

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

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

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

• Perform the daily monitoring of manufacturing systems.

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

• Perform minor preventative maintenance tasks on the equipment.

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

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

• Perform all jobs in a safe and efficient manner.

• Perform all other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

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

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

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

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

5. Sample materials, bulks and finished goods.

6. Perform other duties as assigned.

Basic Job Functions:

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

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Essential Functions of the Job:

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

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

Basic Job Functions:

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

?

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.