Senior QA Batch Records Leader

Pyramid Pharma Services, Inc.; Costa Mesa (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Pyramid Pharma Services, Inc. in Costa Mesa, CA seeks a Sr. Specialist, QA Batch Review to lead complex batch record reviews ensuring FDA/EMA compliance and QMS conformance. This senior SME mentors junior staff and drives quality improvements across the CDMO environment.

You will review testing reports, deviations, and CAPA, support inspections, and collaborate with manufacturing, regulatory affairs, and R&D to embed quality throughout product lifecycle.

Qualifications

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field.
• 5-8 years of progressive experience in batch record review and/or product release in GMP.
• Demonstrated CDMO or pharmaceutical manufacturing operations experience.
• Experience supporting regulatory inspections (FDA, EMA) is preferred.

Responsibilities

• Lead complex batch record reviews and ensure regulatory compliance.
• Mentor Associate Specialist and Specialist staff.
• Support internal audits and regulatory inspections as SME.
• Drive CAPA, deviation, and change control activities.
• Collaborate across QA, manufacturing, R&D, and regulatory affairs.

Skills

Batch record review

Regulatory compliance

Mentoring junior staff

Risk management

Quality systems

Education

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field

Tools

eQMS

Microsoft Office

Job description

Pyramid Pharma Services, Inc. in Costa Mesa, CA seeks a Sr. Specialist, QA Batch Review to lead complex batch record reviews ensuring FDA/EMA compliance and QMS conformance. This senior SME mentors junior staff and drives quality improvements across the CDMO environment.

You will review testing reports, deviations, and CAPA, support inspections, and collaborate with manufacturing, regulatory affairs, and R&D to embed quality throughout product lifecycle.