Senior QA Specialist — GMP Manufacturing Oversight

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

Benefits offered by this job

Healthcare benefits

401k match

Paid time off

Job summary

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

The role serves as the primary QA representative during manufacturing and warehouse operations, supporting investigations and quality systems. Responsibilities include line clearance, QA review and release of materials, calibration and instrument documentation audits, and approving IQ/OQ/PQ documents.

Qualifications

• Bachelor’s degree in chemistry or biology or equivalent experience.
• 8+ years in a cGMP/FDA regulated environment (manufacturing/QC or QA).
• Thorough GMP knowledge and analytical techniques.
• Experience writing or reviewing SOPs and batch records.

Responsibilities

• Provide QA oversight during manufacturing and warehouse operations.
• Perform line clearance activities before manufacturing and packaging.
• Review and release of raw materials and GMP materials per procedures.
• Review/approve batch records, logbooks, and related cGMP documents.
• Support investigations and quality systems.
• Gowning and aseptic processing oversight.

Skills

QA oversight

cGMP knowledge

GMP regulatory knowledge

Document review

SOP writing

CAPA handling

Batch record review

Investigations support

Education

Bachelor’s degree in chemistry or biology

Job description

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

The role serves as the primary QA representative during manufacturing and warehouse operations, supporting investigations and quality systems. Responsibilities include line clearance, QA review and release of materials, calibration and instrument documentation audits, and approving IQ/OQ/PQ documents.