2nd Shift QA Associate I - GMP & Batch Release

BioSpace

Irvine (CA)

On-site

USD 41,000 - 44,000

Full time

7 days ago

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Benefits offered by this job

Medical Dental Vision Life

Voluntary Accident Hospital Pet

401K

Generous Time Off

Job summary

Siegfried is seeking a QA Associate I to support QA operations on the 2nd Shift, focusing on QA Production Floor support and QA Product Release. Schedule: 2 PM - 10:30 PM, Monday through Friday, with potential overtime.

Responsibilities include line clearance, visual inspection, and batch record review to ensure cGMP compliance. Qualifications include a Bachelor's in a related field and 1–2 years in QA/manufacturing within GMP-regulated environments.

Qualifications

QA principles in pharmaceutical or FDA-regulated environments.
Proficient computer skills.
Strong attention to detail and accuracy.
Strong written and verbal communication skills.
Willingness to work overtime/weekends as needed.

Responsibilities

Support QA Production Floor and QA Product Release on 2nd Shift.
Perform line clearance, chart review, calibration verification, and in-process QA checks.
Perform AQL and Level II visual inspections for finished products.
Prepare samples for QC testing and support GMP deviation investigations.
Review batch records for compliance and integrity; resolve discrepancies.
Utilize SAP, LIMS, and TrackWise for data collection and batch review.
Initiate Certificates of Conformance and prepare records for release.