GMP Auditor - Aseptic Processing (Contract)
Location: United States
Time Type: Full-time
Posted on: 14 Days Ago
Job Requisition ID: JR 7069
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About ProPharma:
For over 20 years, ProPharma has supported biotech, med device, and pharmaceutical organizations by offering expertise that drives scientific breakthroughs and introduces new therapies. ProPharma provides consulting solutions that de-risk and accelerate high-profile drug and device programs, with deep knowledge in regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology.
Position Overview:
The GMP Auditor will be responsible for planning and executing GMP audits related to aseptic processing, sterile compounding, and sterility assurance. This role includes conducting audits for qualification, re-qualification, for-cause, and PAI readiness, as well as serving as a subject matter expert (SME) on GMP auditing and supplier management projects. The GMP Auditor will independently manage GMP audit projects and provide consulting services to clients, ensuring compliance with GMP regulations and internal policies.
Key Responsibilities:
Serve as a SME for GMP auditing and aseptic processing projects, particularly in sterile compounding and sterility assurance.
Conduct audits of sterile compounding facilities, cleanrooms, and aseptic processing environments, evaluating compliance with regulatory requirements (USP <797>, FDA guidelines, ICH).
Assess cleanroom behavior, gowning procedures, environmental monitoring, and contamination control during audits.
Evaluate sterility assurance practices, including validation of aseptic processes, media fills, and sterilization methods.
Implement a risk-based GMP audit program with a focus on sterile product manufacturing and compounding.
Provide guidance on corrective and preventive actions (CAPA) to resolve deviations and non-conformances.
Assist clients and ProPharma team in adhering to quality systems, regulatory compliance, and GMP auditing procedures.
Promote GMP expertise through publications and presentations in professional networks.
Review and approve GMP documentation, including protocols, reports, and SOPs.
Audit supplier management and GMP auditing projects for consistency and quality.
Manage multiple projects and interact positively with clients and team members.
Qualifications:
Education: B.S./B.A. in a scientific discipline (Graduate degree preferred).
Experience: At least 5 years of experience in GMP auditing and supplier management, with specific experience in sterile manufacturing and aseptic processing.
Technical Skills:
Strong working knowledge of USP <797>, FDA aseptic processing guidelines, and sterile compounding practices.
Familiarity with contamination control, personnel gowning, and environmental monitoring principles.
Proven ability to conduct audits, risk assessments, and gap analyses in GMP compliance.
Strong editorial skills for reviewing GMP documentation.
Communication Skills: Excellent written and verbal communication, with effective persuasion and presentation skills.
Leadership and Organizational Skills:
Supervisory experience and ability to manage multiple projects.
Strong problem-solving skills and ability to interact with clients and teams effectively.
Additional Skills:
Ability to balance safety, quality, productivity, cost, and employee relations.
Experience with team leadership and managing client relationships.
Workplace Commitment:
ProPharma is an Equal Opportunity Employer, committed to diversity, equity, and inclusion. We provide a safe and empowering space for all employees to thrive and contribute their innovative, entrepreneurial spirit.
Additional Information:
ProPharma does not accept unsolicited resumes from recruiters or third-party agencies.
No phone calls or emails regarding this posting, please.
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