Provide on‑the‑floor QA oversight for biopharma manufacturing: review batch records, perform line clearance, support QC activities, approve shipments, manage deviations/CAPAs/change controls/investigations/holds, support regulatory inspections, ensure GMP compliance, and maintain document control and procedures.
Our client, a world leader in biotechnology and life sciences, is seeking a "QA Specialist (Biotech / Pharmaceutical manufacturing).
Location: Oceanside, CA
Duration: Long-Term Contract (Possibility Of Further Extension)
Pay Rate: $45/hr on W2
Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K
Job Summary:
This role provides on‑the‑floor QA oversight, batch record review, QC support, and ensures compliance with regulatory and site quality standards.
Key Responsibilities:
• Review batch records, perform line clearance, and provide floor QA support
• QA oversight of QC activities (method transfer, COAs, stability)
• Approve shipments and support packaging operations
• Manage deviations, CAPAs, change controls, investigations, and hold events
• Support regulatory inspections and GMP compliance
• Perform walkthroughs, document control tasks, and update procedures/forms
Preferred Skills:
• QC experience (analytical, virology, microbiology)
• Strong GMP knowledge (US/EU)
• MS Office; Veeva/Smartsheet/LIMS a plus
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