On-Floor QA Supervisor - Sterile Drug Manufacturing

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

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