QA Operations Specialist

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:

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• Review batch records, production logs, and equipment documentation for GDP compliance.
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• Perform shop-floor QA walkthroughs and provide real-time documentation support.
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• Support deviation investigations, CAPA tracking, and document control activities.
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• Review raw material records and CoAs; maintain QA tracking logs and metrics.
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Qualifications of the QA Operations Specialist include:

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• Bachelor's degree in Life Sciences, Biotechnology, or a related field.
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• 3+ years of QA experience in a cGMP biotech or pharmaceutical environment.
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• Knowledge of cGMP, GDP, ALCOA+, and data integrity principles.
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• Strong attention to detail, organization, communication, and time-management skills.
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*No C2C or Sponsorship is available at this time*

*Compensation will scale based on experience and fit*