Quality Assurance Operations Supervisor

BioPhase Inc.; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

BioPhase Inc. seeks an experienced Quality Assurance Operations Supervisor for a sterile drug‑product manufacturing facility in Irvine, CA.

The role is hands‑on and on the manufacturing floor about 90% of time, providing real‑time QA oversight and risk‑based decisions to keep operations compliant and release‑ready. You’ll lead 4–5 QA Technicians/Associates, ensure GMP compliance, supervise batch‑record review, deviations, CAPA, and environmental monitoring, partnering with cross‑functional teams

Qualifications

• Bachelor’s degree in a scientific field required.
• Minimum 4 years in QA/QC/manufacturing in GMP‑regulated environment.

Responsibilities

• Supervise 4–5 QA Technicians/Associates on daily manufacturing operations.
• Spend ~90% on the manufacturing floor for real‑time QA support and risk assessment.
• Provide QA oversight for aseptic processes, filling, inspection, and packaging.
• Review batch records in real time for accuracy, traceability, and ALCOA+ data integrity.
• Lead deviation investigations using structured root‑cause analysis (5 Whys, Fishbone).
• Coordinate CAPA and changes with cross‑functional teams to ensure compliance.
• Maintain inspection readiness and support audits and regulatory inspections.

Skills

QA on floor

Supervisory leadership

ALCOA+ data integrity

Good Documentation Practices

Risk assessment

Root cause analysis

Cross-functional collaboration

Environmental monitoring

Education

Bachelor’s degree in Chemistry/Biology/Engineering

Tools

TrackWise

Veeva

MasterControl

SAP

LIMS

eQMS

Job description

Department: Quality Assurance / Quality Control

Reports To: Senior QA Operations Manager

BioPhase is seeking an experienced, hands‑on Quality Assurance Operations Supervisor for a pharmaceutical manufacturing environment in Irvine, CA. This is a highly visible leadership role for a quality professional who is comfortable spending approximately 90% of their time on the manufacturing floor, providing real‑time QA oversight and making risk‑based quality decisions in support of sterile drug‑product operations.

The successful candidate will lead a team of approximately 4 to 5 QA Technicians and QA Associates, supporting aseptic formulation, filling, inspection, packaging, batch‑record review, environmental monitoring, and day‑to‑day GMP compliance. This person will serve as a key quality presence on the shop floor, helping ensure manufacturing operations remain compliant, inspection‑ready, efficient, and aligned with product‑quality and data‑integrity expectations.

What You’ll Do

• Supervise, coach, schedule, and develop a team of 4 to 5 QA Technicians and QA Associates supporting daily manufacturing operations.
• Spend approximately 90% of working time on the manufacturing floor, providing real‑time QA support, operational verification, line clearance, and in‑process oversight.
• Provide QA oversight for aseptic formulation, compounding, filling, visual inspection, packaging, and related pharmaceutical manufacturing operations.
• Perform routine production‑floor walkthroughs and audits in ISO 8 cleanroom environments to verify compliance with SOPs, cGMP requirements, safety standards, and Good Documentation Practices.
• Review batch records in real time for accuracy, completeness, traceability, and compliance with ALCOA+ data‑integrity principles.
• Resolve documentation discrepancies and support timely completion and transfer of batch records to minimize release cycle delays.
• Act as the primary QA contact for on‑floor deviations, ensuring prompt documentation, initial risk assessment, appropriate containment, and escalation of critical events.
• Support deviation investigations using structured root‑cause analysis tools, including 5 Whys and Fishbone analysis.
• Partner with Manufacturing, QC, Microbiology, Validation, and other cross‑functional teams to resolve quality issues while protecting product quality and compliance.
• Support environmental‑monitoring activities, assess excursions in real time, and coordinate appropriate responses with Manufacturing and Microbiology.
• Ensure compliance with aseptic technique, gowning practices, cleanroom behavior, and validated manufacturing procedures.
• Support Aseptic Process Simulations/media fills, including documenting and reviewing interventions.
• Monitor and report quality performance indicators, including batch‑record error rates, right‑first‑time performance, and review‑cycle timelines.
• Serve as a frontline QA representative during internal audits, client audits, and regulatory inspections.
• Maintain inspection readiness and promote a strong quality culture across manufacturing operations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Engineering, or another closely related scientific field.
• At least 4 years of experience in Quality Assurance, Quality Control, Manufacturing, or a comparable GMP‑regulated environment.
• At least 2 years of direct supervisory or people leadership experience, including responsibility for assigning work, managing daily priorities, coaching employees, conducting performance feedback, and supporting employee development.
• Experience directly leading or supervising a team is strongly preferred.
• Pharmaceutical industry experience is required; experience in sterile drug product manufacturing, aseptic processing, or a pharmaceutical CDMO environment is highly preferred.
• Hands‑on experience supporting manufacturing operations in an ISO 8 cleanroom environment.
• Strong working knowledge of cGMP requirements, Good Documentation Practices, batch‑record review, deviation management, CAPA, and change‑control processes.
• Familiarity with FDA 21 CFR Parts 210 and 211, data integrity principles, and ALCOA+ expectations.
• Experience working with electronic quality or manufacturing systems such as TrackWise, Veeva, MasterControl, SAP, LIMS, eQMS, or comparable systems.
• Strong technical writing, documentation review, investigation, problem‑solving, and risk‑assessment skills.
• Ability to make sound, real‑time, risk‑based quality decisions in a fast‑paced manufacturing environment.
• Excellent communication skills and ability to work effectively with manufacturing operators, technical teams, quality partners, clients, and auditors.

Preferred Qualifications

• Experience in sterile, aseptic, injectable, parenteral, biologics, or other high‑risk pharmaceutical manufacturing environments.
• Experience supporting environmental monitoring, sterility assurance, cleanroom qualification, or microbiological excursions.
• Experience with SCADA or other manufacturing‑monitoring systems.
• Experience supporting media fills, aseptic interventions, visual inspection, packaging, or batch release operations.
• Background in a multi‑product CDMO environment.
• Experience serving as a subject‑matter expert during FDA, client, or internal quality audits.