Quality Assurance Operations Supervisor - 2nd Shift

Siegfried•Irvine, CA

1d•$80,000 - $95,000•Onsite

About The Position

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.

Requirements

Strong knowledge of FDA 21 CFR Parts 210/211, EU GMP, and EU Annex 1
Experience with aseptic processing, environmental monitoring, and sterility assurance programs
Proficiency with electronic systems (e.g., LIMS, SAP, TrackWise, eQMS)
Solid understanding of data integrity principles (ALCOA+)
Strong leadership and team management capability
Excellent technical writing and documentation skills (inspection-ready)
Advanced problem-solving and risk assessment ability
Strong communication skills for regulatory, client, and cross-functional interactions
Ability to make real-time, risk-based quality decisions in a fast-paced environment
High attention to detail and operational discipline
BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
4-6 years' experience in Quality Assurance / Manufacturing environment in Pharmaceutical or other GMP regulated industries required

Nice To Haves

Direct experience in sterile/aseptic manufacturing operations (Grade A–D cleanrooms) strongly preferred
Experience in multi-product CDMO environments preferred

Responsibilities

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 critical quality issues impacting patient safety or regulatory compliance.
Develop and maintain the team training matrix to ensure 100% compliance with GMP and job-specific qualifications.
Design and oversee onboarding programs to ensure rapid and effective integration of new hires.
Provide real-time coaching on aseptic techniques, gowning compliance, documentation practices, and professional communication.
Conduct performance evaluations and establish measurable development goals for all direct reports.
Identify high-potential employees and support cross-training and career development opportunities.
Manage performance improvement plans (PIPs) as needed to address performance gaps.
Maintain constant inspection readiness in accordance with FDA, EMA, and international regulatory expectations.
Ensure compliance with internal SOPs, quality systems (deviation, CAPA, change control), and client-specific requirements.
Support audit responses, including investigation support, root cause determination, and CAPA effectiveness.
Promote a culture of quality, compliance, and continuous improvement across operations.