GMP Auditor (Contract) jobs in United States
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ProPharma · 15 hours ago

GMP Auditor (Contract)

positionRaleigh, NC
timeFull-time, Contract
remoteOnsite
senioritySenior Level
date5+ years exp

ProPharma has been enhancing patient health and wellness for over 20 years by providing expert advice to biotech, med device, and pharmaceutical organizations. The GMP Auditor will be responsible for planning and conducting GMP audits, serving as a subject matter expert in compliance with FDA regulations.

BiopharmaMedicalPharmaceutical
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H1B Sponsor Likelynote

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
Specific experience in the following areas: Mock PAI, Medical Devices and Analytical QC Lab

Qualification

GMP auditingFDA regulationsGMP documentationQuality orientationEffective communication

Required

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

Preferred

a graduate degree in a scientific discipline

Company

ProPharma

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At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market.
dateFounded in 2001
location
Overland Park, Kansas, USA
people-size1001-5000 employees
web-link
http://www.propharmagroup.com/

H1B Sponsorship

ProPharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (6)
2022 (4)

Funding

Current Stage
Late Stage
Total Funding
$8.63M
Key Investors
Jump Capital
2020-10-23Series Unknown· $8.63M
2020-09-22Acquired
2015-03-25Series Unknown

Leadership Team

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Dawn Sherman
CEO and Board Chair
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Brian Tuttle
Chief Financial Officer
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Recent News

PR Newswire
Cell and Gene Therapy Market to Exceed US$105B by 2033, Driving Strategic Value Across Healthcare Portfolios | According to DataM Intelligence
2025-12-29
prnasia.com
ProPharma Expands Operations with New Office in Hyderabad
2025-12-11
PR Newswire
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
2025-12-05
Company data provided by crunchbase