Senior QA Batch Review Lead for GMP Compliance and CAPA

Automatic Data Processing, Inc.; Costa Mesa (CA); On-site; USD 75,000 - 92,000; Full time

Job summary

Automatic Data Processing, Inc. is seeking a Sr. QA Specialist in Costa Mesa, CA to lead complex batch record reviews ensuring FDA/EMA compliance within a CDMO environment.

The role entails mentoring junior staff, driving quality improvements, and representing QA during inspections. The ideal candidate possesses 5–8 years of GMP batch record experience, expert knowledge of quality systems, and strong collaboration across manufacturing, R&D, and regulatory affairs.

Qualifications

• Bachelor's degree required in a science/engineering discipline.
• 5-8 years progressive batch record review experience in GMP environments.
• Experience with CDMO or pharmaceutical manufacturing operations preferred.
• Experience supporting FDA/EMA regulatory inspections is a plus.

Responsibilities

• Lead advanced batch record review for complex campaigns and ensure regulatory compliance.
• Review and approve draft batch records prior to manufacturing.
• Mentor junior QA staff and support training programs.
• Drive CAPA, deviation and change control activities and ensure effective closure.

Skills

GMP compliance

Batch record review

Regulatory audits

Quality systems

Mentoring juniors

Education

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering

Tools

eQMS

MS Office

Job description

Automatic Data Processing, Inc. is seeking a Sr. QA Specialist in Costa Mesa, CA to lead complex batch record reviews ensuring FDA/EMA compliance within a CDMO environment.

The role entails mentoring junior staff, driving quality improvements, and representing QA during inspections. The ideal candidate possesses 5–8 years of GMP batch record experience, expert knowledge of quality systems, and strong collaboration across manufacturing, R&D, and regulatory affairs.