QA Operations Lead - 2nd Shift, Pharma Manufacturing

BioSpace; Irvine (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life

Voluntary Accident, Hospital, Pet

401K

Generous Time Off Structure including

Job summary

Lead QA Operations Supervisor (2nd Shift) at Siegfried, onsite on the production floor supporting sterile and aseptic manufacturing. Oversee QA professionals, collaborating with Manufacturing, Validation, Engineering, and Microbiology to ensure safe, compliant, and high-quality production for patients.

Build a strong quality culture, coach teams, and drive continuous improvement in a fast-paced GMP environment. This role emphasizes real-time oversight, regulatory readiness, and patient safety.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific discipline.
• 4-6 years of experience in Quality Assurance, Quality Operations, or Manufacturing within GMP environments.
• Demonstrated supervisory or people leadership experience.
• Strong understanding of cGMP requirements, FDA regulations, and quality systems.
• Excellent communication, coaching, problem-solving, and decision-making skills.
• Proven ability to make sound, risk-based quality decisions in a fast-paced manufacturing environment.

Responsibilities

• Lead a team of QA Technicians and QA Associates on second shift.
• Manage shift staffing, work assignments, priorities, and shift handoffs.
• Provide coaching and leadership that strengthens quality culture, accountability, and team performance.
• Foster a collaborative environment focused on continuous improvement and operational excellence.
• Serve as the primary QA leader supporting second-shift sterile and aseptic manufacturing operations.
• Provide real-time quality oversight for formulation, compounding, filling, visual inspection, and packaging activities.
• Perform in-process verifications, line clearances, operational observations, and batch record reviews.
• Maintain an active presence on the manufacturing floor to ensure compliance with cGMP requirements, SOPs, data integrity principles, and sterility assurance practices.
• Observe aseptic techniques, gowning practices, and critical interventions to support product quality and patient safety.
• Support investigations, deviations, CAPAs, and root cause analysis activities.
• Evaluate quality events and partner cross-functionally to resolve issues and drive sustainable improvements.
• Promote Right-First-Time documentation practices and ALCOA+ data integrity principles.
• Monitor quality performance and identify opportunities to strengthen compliance and operational effectiveness.
• Support a culture of continuous inspection readiness.
• Serve as a Quality representative during client audits, customer visits, and regulatory inspections.

Skills

Communication

Coaching

Problem-solving

Decision-making

Leadership

Quality systems knowledge

FDA regulations knowledge

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific discipline

Tools

TrackWise

SAP

LIMS

Job description

Lead QA Operations Supervisor (2nd Shift) at Siegfried, onsite on the production floor supporting sterile and aseptic manufacturing. Oversee QA professionals, collaborating with Manufacturing, Validation, Engineering, and Microbiology to ensure safe, compliant, and high-quality production for patients.

Build a strong quality culture, coach teams, and drive continuous improvement in a fast-paced GMP environment. This role emphasizes real-time oversight, regulatory readiness, and patient safety.