Quality Assurance Associate I - 2nd Shift
Siegfried · Irvine, CA
QualityFull-timeCompany career page
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Role summary
Quality Assurance Associate I supporting manufacturing operations and batch documentation on the 2nd shift at a pharmaceutical CDMO. The role involves production floor QA checks, batch record review, and product release activities in a GMP-regulated environment.
What they're looking for
- Bachelor's degree in Biochemistry, Chemistry, Engineering, Biology, or related field
- 1-2 years QA or manufacturing experience in pharmaceutical or GMP-regulated industries
- Working knowledge of QA principles in FDA-regulated pharmaceutical environments
- Proficiency with computer systems and software (SAP, LIMS, TrackWise)
- Strong attention to detail and written/oral communication skills
- Ability to work overtime and weekend shifts as needed
What you'll be doing
- Provide QA support to manufacturing personnel for compounding and in-process checks on production floor
- Perform line clearance verification, sterilization review, and visual inspections including CSIT/PID and weight checks
- Review executed batch records for completeness, accuracy, and compliance with procedures and GDP
- Enter and verify batch data into product log sheets and maintain databases; manage GMP documentation
- Participate in deviation investigations and CAPA implementation; initiate Certificates of Conformance
Compensation$30-32/hour plus 10% differential for 2nd shift (2 PM-10:30 PM)
Privacy & handoff
This role links to Siegfried's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.