Senior QA Specialist, GMP Manufacturing

American Regent, Inc.; Brea (CA); On-site; USD 91,000 - 101,000; Full time

Job summary

American Regent, Inc. is seeking a Quality Assurance Specialist to provide real-time QA oversight on the manufacturing floor, ensuring cGMP compliance, regulatory adherence, and internal procedure conformance.

You will review batch records, perform line clearances, supervise aseptic processing, and support investigations and quality systems. A Bachelor’s in chemistry or biology and 8+ years in a cGMP/FDA environment are required.

Qualifications

• Bachelor's degree in chemistry or biology or equivalent combination of education and experience.
• 8+ years in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
• Broad knowledge of scientific theories, instrumentation, and analytical techniques.
• Thorough knowledge of GMPs and pharmaceutical products.
• Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations.
• Experience in writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc.
• Ability to read documents in Standard English (SOPs, maintenance schedules, manuals).

Responsibilities

• Provide QA oversight during manufacturing and warehouse operations.
• Perform line clearance activities before manufacturing and packaging operations.
• Review and release of raw materials and GMP materials per procedures.
• Conduct routine GMP observations of facilities, processes, and personnel.
• Monitor production schedules and ensure QA coverage.
• Review/approve batch records, logbooks, and related cGMP documents.
• Author/Review/approve IQ/OQ/PQ of instruments, protocols, and reports as needed.
• Support investigations and quality systems as required.

Skills

QA oversight

cGMP knowledge

Batch records

Line clearance

Documentation

8+ years cGMP/FDA experience

GMP experience

Education

Bachelor's degree in chemistry or biology

Job description

American Regent, Inc. is seeking a Quality Assurance Specialist to provide real-time QA oversight on the manufacturing floor, ensuring cGMP compliance, regulatory adherence, and internal procedure conformance.

You will review batch records, perform line clearances, supervise aseptic processing, and support investigations and quality systems. A Bachelor’s in chemistry or biology and 8+ years in a cGMP/FDA environment are required.