Senior QA Operations Specialist
technical sourceRaleigh (NC)
Senior QA Operations Specialist
Posted 7 days ago
technical sourceRaleigh (NC)
SENIORITY
Senior
About the role
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*
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