Quality Assurance Operations Supervisor, Pharmaceutical Manufacturing - 2nd Shift

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, Validation, Microbiology, and Site Leadership

✔ Gain valuable exposure to client programs, regulatory inspections, and complex sterile manufacturing operations

✔ Make a direct impact on product quality, compliance, operational performance, and patient safety every day

Schedule

Onsite leading the 2nd Shift Team: 2:00 PM - 10:30 PM

Compensation

Target Salary Range: $80,000 - $95,000 annually

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Apply today and bring your Quality leadership expertise to a team where your impact can be seen in every shift, every batch, and every treatment we help deliver to patients.