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*
QA Operations Specialist in chapel hill at Unknown Company
This position is listed as contract and onsite.