Senior QA Auditor - GMP, FDA Readiness & Audits

BioPhase Inc.; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

BioPhase Solutions is seeking a QA Specialist III/IV (auditing) to act as the senior quality leader for a contract development and manufacturing lab in Orange County. You will host client audits, drive inspection readiness, and lead investigations across LIMS and chromatography systems, ensuring data integrity and CAPA effectiveness.

The role requires 5+ years of GMP quality experience with an advanced degree or 8+ years with a bachelor’s in a related field; familiarity with 21 CFR Part 211, FDA

Qualifications

• 5+ years of GMP laboratory quality experience with a master’s degree in Biosciences or Regulatory, or 8+ years with a bachelor’s degree.
• Demonstrated experience hosting client audits and regulatory inspections.
• Strong knowledge of 21 CFR Part 211, FDA Data Integrity, USP General Chapters, and cGMP guidelines.

Responsibilities

• Provide technical leadership for all quality systems and drive inspection readiness.
• Serve as primary QA host during client audits and regulatory inspections.
• Lead complex investigations (OOS, OOT, data integrity issues) and CAPA effectiveness reviews.
• Oversee computerized systems like LIMS and chromatography data systems, and support validation.
• Supervise QA staff and support onboarding of laboratory personnel; manage supplier quality activities.
• Coordinate internal audits and standardize audit activities.

Skills

Quality leadership

Audit hosting

Regulatory knowledge

Data integrity

CAPA & investigations

GMP experience

Education

Master’s degree in Biosciences or Regulatory

Bachelor’s degree in scientific/regulatory discipline

Tools

LIMS

Chromatography data systems

Electronic records

Audit trail review programs

Job description

BioPhase Solutions is seeking a QA Specialist III/IV (auditing) to act as the senior quality leader for a contract development and manufacturing lab in Orange County. You will host client audits, drive inspection readiness, and lead investigations across LIMS and chromatography systems, ensuring data integrity and CAPA effectiveness.

The role requires 5+ years of GMP quality experience with an advanced degree or 8+ years with a bachelor’s in a related field; familiarity with 21 CFR Part 211, FDA