Quality Assurance Specialist - GMP experience required!

Innovative biotechnology company that manufacturers advanced cell and gene therapy seeks an experienced Quality Assurance Specialist to join the team!

  • College Station, TX
  • $95,000
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A bit about us:

A growing biotechnology company focused on advanced cell and gene therapies!

Why join us?

Newly built 45,000 sq foot GMP facility in College Station, TX!

Job Details

  • Provide Quality oversight to Deviations, Change Controls, CAPAs, New Product Introductions (NPIs), Quality Control Assays (QCAs), and Batch Records (BRs) to ensure that GMP products are manufactured, tested, stored, and distributed according to cGMPs and other applicable regulations.
  • Review of Batch Records on the manufacturing floor ensuring completeness, accuracy of routine work as well as footnotes/comments documented by Manufacturing staff.
  • Apply knowledge of and adhere to cGMPs, company Quality Policies and site Standard Operating Procedures.
  • Advise departments on proper documentation requirements as needed.
  • Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits on-a-monthly basis for Senior Management.
  • Make sound decisions regarding compliance-related issues with moderate supervision.
  • Evaluate compliance issues and interact with regulatory inspectors and client auditors.
  • Perform other duties as assigned
  • Bachelor’s degree in a life science.
  • 3-5 years of cGMP experience in QA or Manufacturing with an emphasis in Cell and Gene Therapy.
  • Gowning qualification is required for this position.

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College Station, TX
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