Verification-GMP Auditor ( REMOTE)

$83,500 - $106,250/Yr

Usp - Rockville, MD

Full-time - Mid Level

Onsite - Rockville, MD

1,001-5,000 employees

Construction of Buildings

About the position

The Verification-GMP Auditor at the U.S. Pharmacopeial Convention (USP) is a non-supervisory, hands-on technical role responsible for conducting onsite Good Manufacturing Practice (GMP) facility audits and reviewing quality control manufacturing documentation for products submitted into the USP Verification Program. This position contributes to USP's mission of enhancing public health by ensuring the quality and safety of medicines and dietary supplements through rigorous auditing and compliance processes.

Responsibilities

• Review initial audit information submitted by participants and assess readiness for formal audits.
• Conduct GMP site audits of manufacturing facilities for dietary supplements, APIs, excipients, and dietary ingredients according to GMP guidelines.
• Prepare timely audit reports summarizing site audit results and compliance assessments.
• Collaborate with USP GMP auditors at various locations to support thorough audits of manufacturing facilities.
• Perform detailed reviews of quality control and manufacturing documents to ensure compliance with verification requirements.
• Prepare reports based on observations and correspond with program participants to ensure corrective actions are implemented.
• Ensure compliance with verification procedures in the preparation of summary reports and approval letters.
• Create work schedules with verification staff and other departments regarding verification programs.
• Conduct surveillance activities to ensure audits and documentation reviews are conducted per program requirements.
• Develop and revise standard operating procedures (SOPs) and participant manuals.

Requirements

• Master's degree in Analytical Chemistry, Biochemistry, or related fields with a minimum of five years of relevant experience, or a Bachelor's degree with seven years of relevant experience.
• Relevant experience as a GMP auditor in cGMP facilities engaged in pharmaceuticals and/or dietary supplements.
• Industry auditing experience in establishing quality systems compliance.
• Willingness to travel approximately 25% domestically and internationally.
• Certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is required.

Nice-to-haves

• Knowledge of GMP audits using 21 CFR parts 111 and 117.
• Extensive knowledge of FDA regulations pertaining to cGMP requirements.
• Working knowledge of ICH quality guidelines and the Common Technical Document (CTD) for APIs.
• Effective project management experience.
• Third-party quality certification/verification experience in the pharmaceutical or dietary ingredient/supplement industry.

Benefits

• Paid time off
• Comprehensive healthcare options
• Retirement savings
• Target Annual Bonus: 10%