Senior QA Operations Specialist
Full-time
Technical Source
Technical Source is currently in search of a Senior QA Operations Specialist for our biotechnology client in the Raleigh-Durham-Chapel Hill Area. This is a contract position that requires on-site work. The qualified candidate should have experience supporting quality operations on the floor of a drug substance or cell/gene therapy environment.
Responsibilities of the Senior QA Operations Specialist include:
- Perform shop-floor QA oversight, GEMBA walkthroughs, and room releases.
- Conduct primary and secondary reviews of batch records, logbooks, and analytical results.
- Lead deviation investigations, root-cause analysis, risk assessments, and CAPA activities.
- Review material documentation, SOPs, batch records, and validation protocols.
Qualifications of the Senior QA Operations Specialist include:
- Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field.
- 7+ years of QA experience in a cGMP biomanufacturing or pharmaceutical environment.
- Expertise in batch record review, GDP, ALCOA+, and deviation investigations.
- Flexibility to support manufacturing shifts, including potential evenings and weekends.
*No C2C or Sponsorship is available at this time*
*Compensation will scale based on experience and fit*
Vacancy posted 3 days ago
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