Quality Assurance Operations Supervisor - 2nd Shift

BioSpace; Irvine (CA); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

401K

Paid time off

Job summary

Siegfried in Irvine, CA, seeks a QA Operations Supervisor to lead a shift of QA Technicians in a sterile GMP‑regulated CDMO setting.

You will ensure real‑time compliance, batch record integrity (ALCOA+), and quick deviation resolution across aseptic filling, inspection and packaging.

The role requires strong knowledge of FDA/EU GMP, data integrity, and audit readiness, plus coaching and developing a compliant, high‑performing team.

Qualifications

• BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline.
• 4-6 years' experience in Quality Assurance / Manufacturing in GMP environments.
• Direct experience in sterile/aseptic manufacturing preferred.
• Experience in multi-product CDMO environments is a plus.

Responsibilities

• Supervise QA Technicians/Associates on shift with task allocation and real-time scheduling.
• Provide QA oversight for aseptic processing, filling, inspection, and packaging.
• Maintain batch record integrity and ALCOA+ compliance prior to QA release.
• Lead investigations using root cause analysis tools and formal CAPA.
• Coordinate with cross-functional teams to resolve issues and ensure product integrity.
• Monitor QA KPIs and ensure timely transfer of batch records for release.
• Act as SME during audits and regulatory inspections on the shop floor.
• Train, coach and develop QA team to ensure GMP readiness.

Skills

QA leadership

Aseptic processing

GMP compliance

Document control

Data integrity ALCOA+

Problem solving

Regulatory knowledge

Leadership

Education

BS degree in Biochemistry, Chemistry, Engineering

Tools

LIMS

SAP

TrackWise

eQMS

SCADA

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

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

Your Profile:

• 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.

Sterility Assurance & Aseptic Oversight

• 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.

Real Time Deviation Management & Technical Support

• 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.

Training, Coaching & People Development

• 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.

Regulatory Compliance & Quality Systems

• 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.

Required Knowledge, Skills And Abilities

• 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

  Required Education And Experience

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

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

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

  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.