Overview
GMP Compliance Officer Jobs in Irvine, CA at BaRupOn LLC
Full Job Description
Job Summary
The GMP Compliance Officer ensures that BaRupOn’s pharmaceutical and sterile manufacturing operations remain fully compliant with current Good Manufacturing Practices (cGMP) and FDA regulations. This associate-level role supports quality audits, documentation review, CAPA tracking, and SOP implementation. The ideal candidate has hands-on experience in GMP environments and strong attention to detail.
Key Responsibilities
Conduct routine GMP compliance checks and internal audits across manufacturing and cleanroom areas
Support deviation investigations, corrective/preventive actions (CAPA), and non-conformance tracking
Review production records, batch logs, and SOPs for accuracy and regulatory alignment
Assist with FDA audit readiness, site inspections, and regulatory responses
Maintain GMP training records and coordinate training sessions with operations staff
Collaborate with Quality Assurance and production teams to resolve compliance issues
Monitor environmental control logs, calibration schedules, and hygiene protocols
Ensure documentation practices meet 21 CFR Part 11 and FDA expectations
Qualifications
Associate degree in Life Sciences, Biotechnology, or Regulatory Compliance (required)
2–4 years of experience in GMP-regulated manufacturing or pharmaceutical quality roles
Familiarity with FDA regulations, cGMP, ICH Q7/Q10, and relevant ISO standards
Detail-oriented with strong documentation and audit readiness skills
Ability to interpret SOPs, quality manuals, and compliance checklists
Preferred Skills
Experience with sterile manufacturing, compounding, or cleanroom environments
Working knowledge of TrackWise, MasterControl, or other QMS platforms
GMP certification or regulatory training a plus (e.g., NSF, PDA, ISPE)
Benefits
Health, dental, and vision insurance
401(k) with employer match
Paid time off and holidays
Career advancement in GMP and regulatory roles
Opportunity to contribute to critical health and energy infrastructure
Title: GMP Compliance Officer
Company: BaRupOn LLC
Location: Irvine, CA
Category:
