GMP Quality Assurance Lead – Data & Vendor Oversight

Aerogen Ltd.; Foster City (CA); On-site; USD 88,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

401k Retirement

Paid Time Off

Job summary

Aerogen Pharma seeks a Quality Specialist to oversee Quality Operations, batch-record reviews, and product disposition in a GMP‑regulated setting. You will participate in audits, support deviations, and drive continuous improvement within the QMS. Strong documentation and vendor oversight are essential for success.

Ideal candidates hold a life-sciences degree and 3+ years in GMP QA, with experience in electronic systems and CMOs. Located near San Mateo, CA, with a robust benefits package.

Qualifications

• Bachelor’s degree in a life sciences or related discipline.
• Minimum 3+ years in regulated industry incl. 2+ years GMP QA, manufacturing, or QC.
• Experience reviewing batch records and supporting product disposition preferred.
• Experience overseeing CMOs or suppliers preferred.

Responsibilities

• Review batch records for manufacturing, packaging, and labeling to ensure accuracy and compliance.
• Verify deviations, OOS, investigations, and CAPAs are properly documented.
• Support lot disposition by preparing QA documentation packets for final review.
• Assist in internal audits and regulatory inspections.

Skills

GMP Knowledge

Documentation practices

QA oversight

eQMS experience

Vendor management

Education

Bachelor’s degree in pharmacy, chemistry, biochemistry, microbiology, engineering, life sciences, or related discipline

Tools

Veeva

TrackWise

MasterControl

SAP

Oracle

Job description

Aerogen Pharma seeks a Quality Specialist to oversee Quality Operations, batch-record reviews, and product disposition in a GMP‑regulated setting. You will participate in audits, support deviations, and drive continuous improvement within the QMS. Strong documentation and vendor oversight are essential for success.

Ideal candidates hold a life-sciences degree and 3+ years in GMP QA, with experience in electronic systems and CMOs. Located near San Mateo, CA, with a robust benefits package.