Biopharma Quality Assurance Specialist (Direct Hir
Company: Kelly Services
Location: College Station
Posted on: September 24, 2022
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
- Support investigations into quality system issues.
- Maintaining a batch release tracking system.
- Close all required deliverables to support the disposition of
- 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.
- 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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