Quality Assurance Operations Supervisor - 2nd Shift

"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:

Make Quality Happen Where It Matters Most

Are you a hands-on Quality Assurance leader with experience in pharmaceutical manufacturing who thrives on the production floor and enjoys making real-time decisions that protect product quality, patient safety, and regulatory compliance?

We are seeking a QA Operations Supervisor to lead our 2nd shift Quality Operations team in a fast-paced pharmaceutical manufacturing CDMO environment. This highly visible role provides direct oversight of a team of QA Technicians and Associates supporting sterile and aseptic manufacturing operations. You''ll serve as a key quality partner to Manufacturing, ensuring cGMP compliance, sterility assurance, data integrity, and inspection readiness while helping drive efficient production execution.

As the quality leader for the second shift, you will be the primary QA presence on the manufacturing floor, providing real-time oversight and guidance for aseptic formulation, compounding, filling, visual inspection, and packaging operations. This role is ideal for a Quality professional who enjoys developing teams, solving complex challenges, and making an immediate impact on product quality and operational success.

Your Profile:

What You'll Do

Lead & Develop the Team

• Supervise, mentor, and develop a team of QA Technicians and QA Associates supporting second-shift manufacturing operations.
• Manage shift scheduling, work assignments, priorities, and handoffs to ensure seamless quality support.
• Provide real-time coaching and leadership to strengthen quality culture and operational performance.
• Foster accountability, teamwork, and continuous improvement throughout the organization.

Be the Quality Presence on the Manufacturing Floor

• Maintain an active presence in manufacturing areas, serving as the primary QA decision-maker during production activities.
• Perform in-process verifications, line clearances, documentation reviews, and operational observations.
• Support aseptic formulation, compounding, filling, visual inspection, and packaging operations.
• Conduct routine walkthroughs in ISO 6-8 cleanroom environments to ensure compliance with GMP requirements, SOPs, environmental controls, and safety standards.
• Observe aseptic techniques, gowning practices, and critical interventions to ensure adherence to validated processes.

Drive Compliance & Quality Excellence

• Champion Right-First-Time documentation practices and ALCOA+ data integrity principles.
• Oversee real-time batch record review activities and facilitate efficient batch progression through manufacturing.
• Monitor quality performance metrics and identify opportunities to improve compliance and operational effectiveness.
• Support a culture of continuous inspection readiness.

Lead Investigations & Risk-Based Decision Making

• Assess manufacturing deviations, equipment issues, and environmental monitoring excursions in real time.
• Participate in deviation investigations using TrackWise and structured root cause analysis tools such as 5 Whys and Fishbone methodologies.
• Evaluate product impact and determine appropriate disposition of non-conforming materials, in-process materials, and finished products.
• Drive effective corrective and preventive actions (CAPAs) that improve long-term quality performance.

Support Audits & Regulatory Readiness

• Serve as the Quality Assurance subject matter expert during client audits, customer visits, and regulatory inspections.
• Partner cross-functionally with Manufacturing, Validation, Engineering, Microbiology, and Quality Systems teams to maintain compliance and operational excellence.

What You Bring

Required Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Engineering, or a related scientific discipline.
• 4-6 years of experience in Quality Assurance, Manufacturing, or Quality Operations within pharmaceutical, biotech, or other GMP-regulated industries.
• Demonstrated experience leading teams or providing functional leadership within a GMP environment.
• Strong understanding of FDA 21 CFR Parts 210/211, EU GMP requirements, and EU Annex 1.
• Excellent communication, technical writing, and problem-solving skills.
• Proven ability to make sound, risk-based quality decisions in a fast-paced manufacturing setting.
• High attention to detail and strong operational discipline.

Preferred Qualifications

• Direct experience supporting sterile and aseptic manufacturing operations in Grade A-D cleanroom environments.
• Experience working within a Contract Development and Manufacturing Organization (CDMO).
• Familiarity with electronic quality and manufacturing systems such as TrackWise, SAP, and LIMS.
• Experience supporting multi-product pharmaceutical manufacturing facilities and customer-focused environments.

Why Join Us?

Lead a critical Quality Operations team supporting life-changing pharmaceutical products.

Join a growing pharmaceutical manufacturing organization with a strong commitment to quality, compliance, and continuous improvement.

Lead and develop a dedicated 2nd Shift team of QA Technicians and Associates supporting sterile manufacturing operations.

Work in a modern sterile manufacturing environment with advanced technologies and diverse product portfolios.

Partner closely with Manufacturing, Engineering, Validation, Microbiology, and Site Leadership to drive operational excellence.

Gain valuable exposure to customer audits, regulatory inspections, and complex CDMO operations.

Make a direct impact on product quality, compliance, and patient safety every day.

2nd Shift: 2 PM -10:30 PM

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 will be seen every shift.

Your Benefits:

• Medical, Dental, Vision, Life
• Voluntary Accident, Hospital, Pet
• 401K
• Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.