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Biopharma Quality Assurance Specialist (Direct Hir

Company: Kelly Services
Location: College Station
Posted on: September 24, 2022

Job Description:

Kelly Science and Clinical is currently seeking candidates for a Quality Assurance Specialist position for a Biopharma company in College Station, TX. The overall responsibility of this role is to provide quality oversight to the disposition of all materials manufactured by the company.Responsibilities:

  • Represent the QA department in internal and external meetings related to batch release.
  • Assist with identifying compliance gaps during internal and external site audits.
  • Provide Quality oversight to Deviations, Change Controls, CAPAs, New Product Introductions (NPIs), Quality Control Assays (QCAs), and Batch Records (BRs).
  • Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
  • Support investigations into quality system issues.
  • Maintaining a batch release tracking system.
  • Close all required deliverables to support the disposition of batches.
  • Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch release process.
  • Track and trend metrics for QA on Deviations, CAPAs, and Change Controls on a monthly basis.
  • Mentor and train less experienced staff members. Qualifications:
    • Bachelor's degree in the sciences, preferably in Microbiology, Biochemistry, Biotechnology, or related.
    • 3-5 years of cGMP experience in QA or Manufacturing with an emphasis in Cell and Gene Therapy.
    • Must possess GMP compliance knowledge including CFR, PICS, and EU guidelines to Good Manufacturing Practices.
    • Ability to become gown qualified. Job Details
      • Job Type: Direct Hire
      • Work Schedule: Monday-Friday, 8:00am-5:00pm
      • Relocation/Sign on Bonus provided If you meet the above qualifications, please submit your resume for immediate consideration for this high priority role!

Keywords: Kelly Services, College Station , Biopharma Quality Assurance Specialist (Direct Hir, Other , College Station, Texas

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