Sr. QA Specialist

Shift Option 1) Wed-Sat 12:30pm est. - 11:00pm est. Shift Option 2) Sun-Wed 12:30pm est. – 11:00pm est.

Description:

- Provide QA floor support in cell/gene therapy manufacturing, including cleanroom activities.

- Perform batch record and QC data reviews to support product disposition and lot release.

- Review and approve deviations, CAPAs, and manufacturing documentation to ensure compliance.

- Support compliance walkthroughs, inspection readiness, and continuous improvement initiatives.

- Qualifications: Bachelor’s degree (Master’s preferred), 3–5 years QA experience in cell/gene therapy, commercial QA/lot disposition exposure, and strong knowledge of GMPs, aseptic processing, and ATMP regulations.

Job Type: Contract

Pay: $50.00 - $65.00 per hour

Expected hours: 40 per week

Benefits:

- 401(k)

- Health insurance

Experience:

- cell/gene therapy QA: 3 years (Required)

- commercial QA operations : 2 years (Required)

- QA on-the-floor support : 2 years (Required)

- QC record review : 2 years (Required)

- Cleanroom: 2 years (Required)

- lot disposition: 2 years (Required)

Work Location: On the road