Demo

GMP QA/QC Tech

Actalent
Cincinnati, OH Other
POSTED ON 5/14/2023 CLOSED ON 5/31/2023

What are the responsibilities and job description for the GMP QA/QC Tech position at Actalent?

In this role you will support a GMP Manufacturing facility by conducting QA/QC checks

RESPONSIBILITIES

• Complete all QA paperwork correctly and completely.

• Complete all required product quality checks.

• Complete QA Testing of products blended in house.

• Read and understand all line folders and verify all materials used on the production lines are correct and all date codes are formatted correctly with the correct pallet type.

• If non-conforming materials are discovered, place on hold, attach Material Hold Tags attached and turn copies of Material Hold Tags into Management.

• Monitor product quality throughout shift so that off quality product is never produced for longer than twenty (20) minutes. Document all non-conformances on the quality check sheets.

• Inform Director of Commercialization & Quality and/or Quality Manager of any issues that occurred during the shift.

• Ensure the Pack Report matches the product being produced on the line and is completed properly.

• Ensure all supervisor verifications are completed and at the required time-frame.

• Ensure all persons in the production area are observing GMP (No gum or candy, wearing hairnets and beard nets properly, wearing gloves if required, etc.) and notify Production Supervisor if not.

• Verify that only the parts and line folder for the product being produced are on the production line (verify line clearance).

• Verify that components brought to the line are correct and document component part number and description as required by paperwork.

• Complete a quick walk around of each pallet of finished goods prior to it being taken out of the production area to ensure that it meets the requirements of the Line Folder.

• Ensure all required testing and sampling is being done, including both in-process and finished goods.

• Supply samples of poor quality finished product found during hourly inspections to the Director of Commercialization & Quality and/or Quality Manger for evaluation.

• Audit the production line for cleanliness. (No empty boxes scattered all over, trashcans not overflowing onto floor, cardboard debris and banding is cleaned up in a timely manner, etc.)

• Review Pack Reports and Batch Records to ensure they are complete and release the resulting product for further processing or shipment to the trade.

REQUIREMENTS

  • HS Diploma or GED
  • Prior experience in regulated manufacturing role
  • Prior experience in QA/QC manufacturing role

1st and 2nd Shift Available

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Salary : $18 - $19

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