Quality Assurance Operations Supervisor - 2nd Shift

Overview

"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.

The Quality Assurance (QA) Operations Supervisor is a critical, hands-on leadership role responsible for ensuring real-time GMP compliance, operational verification, and sterility assurance on the manufacturing floor within a pharmaceutical CDMO environment. This role leads a shift-based team of QA Technicians and Associates, providing direct oversight of aseptic formulation, filling, inspection, and packaging operations to ensure strict adherence to validated processes, regulatory requirements (FDA, EMA, EU Annex
1), and client Quality Agreements. Acting as the primary quality authority on the shop floor, the Supervisor ensures batch record integrity, proactively identifies and manages process deviations, and balances manufacturing efficiency with uncompromised product quality, data integrity (ALCOA+), and inspection readiness. 2nd Shift

Hours:

2 PM - 10:30 PM Monday through Friday

Responsibilities

• Team Leadership & Daily QA Operations
• Supervise and coordinate daily activities of a team of QA Technicians/Associates, including task allocation, shift handovers, and real-time scheduling to ensure continuous production support.
• Provide QA oversight for manufacturing operations including aseptic processing, compounding, filling, visual inspection, and packaging in compliance with cGMP requirements.
• Ensure continuous QA presence on the production floor for in-process verification, line clearance, and real-time decision-making.
• Conduct routine shop floor walkthroughs and audits of ISO 6–8 cleanroom environments to ensure compliance with SOPs, safety standards, and Good Documentation Practices.
• Oversee real-time batch record review, ensuring accuracy, completeness, and compliance with ALCOA+ principles prior to QA release.
• Resolve complex documentation issues and ensure all records are inspection-ready before submission to batch release functions.
• Monitor, trend, and report Quality KPIs (e.g., batch record error rates, review cycle times, right-first-time performance).
• Ensure timely compilation and transfer of completed batch records to minimize release cycle delays.
• Serve as a frontline SME during internal audits, client inspections, and regulatory inspections, effectively representing shop-floor quality practices.

• Enforce strict adherence to aseptic techniques, gowning qualifications, and cleanroom behaviors in Grade A–D / ISO 6–7 environments.
• Oversee environmental monitoring (EM) through SCADA systems and coordinate immediate responses to excursions in collaboration with Microbiology and Manufacturing.
• Assess EM events in real time and support decision-making on operational pauses, product impact, and segregation.
• Monitor aseptic interventions to ensure compliance with validated procedures and accurate documentation in intervention logs.
• Support and oversee Aseptic Process Simulations (Media Fills), ensuring worst-case conditions are appropriately challenged and documented.

• Act as the primary QA contact for on-floor deviations, ensuring immediate and accurate documentation of events and evidence.
• Perform initial risk and impact assessments (Minor/Major/Critical) and implement immediate corrective actions to protect product quality.
• Lead or support structured investigations using root cause analysis tools (e.g., 5 Whys, Fishbone).
• Collaborate cross-functionally (Manufacturing, QC, Microbiology, Validation) to resolve issues while maintaining compliance and product integrity.
• Escalate…