QA Operations Supervisor - Aseptic Manufacturing Compliance

Siegfried; Irvine (CA); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Voluntary Benefits

401K

PTO & Holidays

Job summary

Siegfried in Irvine, CA is seeking a Quality Assurance Operations Supervisor to lead a shift of QA Technicians in a GMP-regulated pharmaceutical CDMO setting. You will ensure real-time QA oversight of aseptic processing, documentation integrity, batch release readiness, and regulatory compliance across FDA/EMA standards.

Responsibilities include supervising daily QA activities, managing deviations, supporting audits, and coaching staff to maintain ALCOA+ data integrity while balancing quality

Qualifications

• BS degree in a life science or engineering field and GMP/regulatory awareness.
• Experience leading QA on aseptic manufacturing within pharma or CDMO settings.
• Strong documentation, deviation handling and CAPA execution.

Responsibilities

• Lead a shift of QA technicians, oversee aseptic operations and batch review.
• Ensure real-time QA presence, ALCOA+ data integrity and release readiness.
• Train and coach staff; partner with manufacturing, QC and regulatory teams.
• Prepare for internal and client audits; ensure inspection readiness.

Skills

QA Leadership

GMP Compliance

Aseptic Processing

Regulatory Knowledge

Team Management

Documentation

Education

BS in Biochemistry

BS in Chemistry

Engineering/Related

Tools

LIMS

SAP

TrackWise

eQMS

Job description

Siegfried in Irvine, CA is seeking a Quality Assurance Operations Supervisor to lead a shift of QA Technicians in a GMP-regulated pharmaceutical CDMO setting. You will ensure real-time QA oversight of aseptic processing, documentation integrity, batch release readiness, and regulatory compliance across FDA/EMA standards.

Responsibilities include supervising daily QA activities, managing deviations, supporting audits, and coaching staff to maintain ALCOA+ data integrity while balancing quality