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QA Specialist

Your role: This individual will work various internal departments to improve and execute processes used in an ICH Q7 environment.

 

  • Lead Process Improvement teams for Quality System related initiatives/projects.
  • Documentation control including: write, review or approve Operation Procedures, Specifications, Master Manufacturing Procedures and other QA-controlled documents. 
  • Ensure that all aspects of product (raw, intermediate, final) release meet analytical, production, packaging and labeling specifications in accordance with established quality systems.
  • Review Root Cause Analysis investigations and ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues.
  • Participate in internal audits as needed.
  • Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Respond to quality-related customer questions.

     

    Who you are:

  • B.S./B.A. in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering and 3+ years experience in industry or advanced degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering and 2-4 years in industry desired.

Experience:

  • Knowledge of ICHQ7 is required
  • Current API knowledge &/or experience desired.
Job Requisition ID:  186648
Location:  St. Louis
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: Biochemistry, Pharmacy, Laboratory, QA, Science, Healthcare, Quality

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