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

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