GMP Compliance Officer
BaRupOn LLCIrvine, CA
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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