Verification-Gmp Auditor ( Remote)

5-7 years

USD $ 83,500.00 – 106,250.00 annually

Remote

10 Dec. 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: GMP Auditor – Dietary Supplements and Pharmaceuticals
Location: Remote/Travel Required

About USP:
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization dedicated to advancing quality standards for medicines, dietary supplements, and food ingredients. At USP, we are committed to equity and excellence, fostering a culture of inclusivity, and ensuring access to safe, high-quality health products worldwide.

Role Overview:
We are seeking a GMP Auditor to join our team. This non-supervisory, hands-on technical position is responsible for conducting Good Manufacturing Practice (GMP) audits at manufacturing facilities, reviewing quality control manufacturing (QCM) documentation, and supporting the USP Verification Program. The GMP Auditor will play a critical role in ensuring compliance with GMP guidelines and contributing to the overall safety and quality of dietary supplements and pharmaceuticals.

Key Responsibilities:

Conduct GMP audits at manufacturing facilities producing dietary supplements, active pharmaceutical ingredients (APIs), excipients, and dietary ingredients.
Assess participant readiness for formal audits and prepare audit reports summarizing compliance with GMP requirements.
Collaborate with USP GMP auditors across locations, supporting audits of manufacturing facilities for dietary supplements and pharmaceutical products.
Review QCM documents and test data to ensure compliance with verification requirements.
Develop corrective action reports and work with program participants to implement improvements.
Contribute to the development and revision of SOPs and participant manuals.
Conduct surveillance audits to ensure ongoing compliance with verification program requirements.
Assist in the preparation of audit schedules and manage verification projects with staff, contract auditors, and laboratories.
Support the growth of the verification services within USP’s fast-paced environment.

Qualifications & Experience:

Education: Master’s degree in Analytical Chemistry, Biochemistry, or related fields with 5+ years of relevant experience or a Bachelor’s degree with 7+ years of experience.
Proven GMP auditing experience in pharmaceutical or dietary supplement manufacturing and quality control.
Familiarity with FDA regulations and GMP requirements (21 CFR Parts 111 and 117).
Certification as a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).
Strong knowledge of GMP regulations, audit procedures, and quality assurance.
International travel (up to 25%) required for facility audits.
Ability to work independently and efficiently in a remote environment.

Additional Desired Skills:

Knowledge of ICH quality guidelines and Common Technical Document (CTD) for APIs.
Experience in third-party quality certification or verification in the pharmaceutical or dietary supplement industry.
Strong project management, organizational, and communication skills.

Benefits:

Competitive salary range: USD $83,500 – $106,250 annually.
Target Annual Bonus: 10% (varies based on role level).
Comprehensive healthcare, paid time off, and retirement savings options.

Note:
USP does not accept unsolicited resumes from third-party recruitment agencies.

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Verification-Gmp Auditor ( Remote)

Job Description

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