Quality Assurance Operations Supervisor, Pharmaceutical Manufacturing - 2nd Shift

Siegfried AG; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Siegfried AG in Irvine, CA seeks a QA Operations Supervisor, 2nd Shift, to lead QA professionals on the production floor in sterile and aseptic manufacturing. You will collaborate with Manufacturing, Validation, Engineering, and Microbiology to ensure products are manufactured safely, in compliance with cGMP, and meet quality standards.

This hands-on, onsite leadership role emphasizes coaching, building a strong quality culture, and timely issue resolution.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or related scientific discipline.
• 4-6 years of experience in Quality Assurance, Quality Operations, or Manufacturing within pharmaceutical, biotechnology, or other GMP-regulated environments.
• Demonstrated supervisory, team lead, 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 & Develop the Team: Supervise, mentor, and develop a team of QA Technicians and QA Associates supporting second-shift operations.
• Manufacturing Quality Oversight: Serve as the primary QA leader for second-shift sterile and aseptic manufacturing.
• Compliance & Continuous Improvement: Support investigations, deviations, CAPAs, and root cause analysis; promote ALCOA+ data integrity and Right-First-Time documentation.
• Audit & Regulatory Support: Represent QA during client audits, customer visits, and regulatory inspections.

Skills

Team leadership

Coaching

Problem-solving

Decision-making

Communication

Quality mindset

Education

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

Tools

TrackWise

SAP

LIMS

Job description

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact.

Your Role:

Lead Quality Where It Matters Most

If you've built your career in pharmaceutical manufacturing and enjoy leading people, developing teams, solving problems in real time, and being where the action happens, we'd love to meet you.

As the QA Operations Supervisor, 2nd Shift, you'll lead a team of QA professionals supporting sterile and aseptic manufacturing operations while serving as the primary Quality leader on the production floor. Working closely with Manufacturing, Validation, Engineering, and Microbiology, you'll help ensure products are manufactured safely, consistently, and in compliance with cGMP requirements. Every decision you make helps support our clients and the patients who rely on the treatments we produce.

This is a hands-on, onsite leadership role for someone who thrives in a fast-paced GMP environment, enjoys coaching and developing others, and takes pride in building a strong culture of quality, compliance, and patient focus. You'll spend much of your time on the manufacturing floor partnering with Operations, supporting production activities, and providing real-time quality oversight where it matters most.

Your Profile:

Key Responsibilities

Lead & Develop the Team

• Supervise, mentor, and develop a team of QA Technicians and QA Associates supporting second-shift operations.
• 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.

Manufacturing Quality Oversight

• 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.

Compliance & Continuous Improvement

• 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.

Audit & Regulatory Support

• Serve as a Quality representative during client audits, customer visits, and regulatory inspections.
• Partner with Manufacturing, Engineering, Validation, Microbiology, and Quality Systems teams to maintain compliance and support operational excellence.

Required 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 pharmaceutical, biotechnology, or other GMP-regulated environments.
• Demonstrated supervisory, team lead, 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.

Preferred Qualifications

• Experience supporting sterile and aseptic manufacturing operations.
• Experience working in a pharmaceutical CDMO environment.
• Knowledge of EU GMP and Annex 1 requirements.
• Experience working within Grade A-D cleanroom environments.
• Familiarity with TrackWise, SAP, LIMS, or other electronic quality systems.
• Experience supporting client audits, customer visits, and regulatory inspections.

Why Join Us?

• Lead and develop a team of Quality professionals supporting sterile manufacturing operations
• Serve as the primary Quality leader for a critical production shift
• Join a growing pharmaceutical CDMO committed to quality, innovation, and continuous improvement
• Partner closely with Manufacturing, Engineering, Valida