QA Operations Specialist
technical sourceRaleigh (NC)
QA Operations Specialist
Posted 7 days ago
technical sourceRaleigh (NC)
SENIORITY
Senior
About the role
Technical Source is currently in search of a 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 QA Operations Specialist include: Review batch records, production logs, and equipment documentation for GDP compliance. Perform shop-floor QA walkthroughs and provide real-time documentation support. Support deviation investigations, CAPA tracking, and document control activities. Review raw material records and CoAs; maintain QA tracking logs and metrics. Qualifications of the QA Operations Specialist include: Bachelor's degree in Life Sciences, Biotechnology, or a related field.3+ years of QA experience in a cGMP biotech or pharmaceutical environment. Knowledge of cGMP, GDP, ALCOA+, and data integrity principles. Strong attention to detail, organization, communication, and time-management skills.*No C2C or Sponsorship is available at this time**Compensation will scale based on experience and fit*
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