GMP Auditor (Contract)

ProPharma Group • Overland Park, KS

2d

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The GMP Auditor (specifically, ex-FDA ) will be responsible for planning and conducting GMP audits (qualification, re-qualification, for-cause, and PAI readiness) on behalf of clients. Serve as a subject matter expert (SME) for GMP auditing in accordance with FDA regulations; specific experience in the following areas: Mock PAI, Medical Devices and Analytical QC Lab.

Requirements

• B.S./B.A. in a scientific discipline; a graduate degree in a scientific discipline is preferred.
• Quality orientation and high attention to detail.
• Experience with creating GMP documentation, including protocols, reports, and SOPs.
• Effective written and oral communication skills, with the ability to convey information and instructions accurately.
• Minimum of 5 years of GMP auditing experience in a related industry
• High-level understanding of GMP auditing services in the pharmaceutical, medical device, and biotech industries.

Nice To Haves

• a graduate degree in a scientific discipline is preferred.

Responsibilities

• planning and conducting GMP audits (qualification, re-qualification, for-cause, and PAI readiness) on behalf of clients.
• Serve as a subject matter expert (SME) for GMP auditing in accordance with FDA regulations

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 251-500 employees