ProPharma · 14 hours ago
GMP Auditor, Med Device (Ex-FDA Preferred)
Raleigh, NC
Full-time
Onsite
Mid LevelProPharma is a company that has been improving health and wellness for 20 years by providing expertise to biotech, med device, and pharmaceutical organizations. They are seeking a GMP Auditor to conduct onsite audits, ensuring compliance with regulatory standards and managing various quality systems.
BiopharmaMedicalPharmaceutical
Responsibilities
Onsite audit in San Diego, CA
SOPs/QMS documents in place
Elements of QMS as they relate to EMA, FDA 21CFR210/211 Production systems
Facilities and equipment system
Materials system
Laboratory controls system
Packaging and labelling system
Vendor contracts and vendor relationships
Product and manufacturing information
Site lay-out and on-site walkthrough of facility
Documentation and records
Records and reports
FDA 21CFR210/211, EUGMP, ICH Q7 compliance, as applicable
Interview of key personnel
Management responsibilities
8-hour instructor led training and interactive workshop; includes preparation & delivery
Qualification
Required
Onsite audit in San Diego, CA
30-hours
SOPs/QMS documents in place
Elements of QMS as they relate to EMA, FDA 21CFR210/211 Production systems
Facilities and equipment system
Materials system
Laboratory controls system
Packaging and labelling system
Vendor contracts and vendor relationships
Product and manufacturing information
Site lay-out and on-site walkthrough of facility
Documentation and records
Records and reports
FDA 21CFR210/211, EUGMP, ICH Q7 compliance, as applicable
Interview of key personnel
Management responsibilities
8-hour instructor led training and interactive workshop; includes preparation & delivery
Preferred
Ex-FDA Preferred
Company
ProPharma
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market.
Founded in 2001
1001-5000 employees
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 StageTotal Funding
$8.63MKey Investors
Jump Capital
2020-10-23Series Unknown· $8.63M
2020-09-22Acquired
2015-03-25Series Unknown
Leadership Team
Dawn Sherman
CEO and Board Chair
Brian Tuttle
Chief Financial Officer
Recent News
2025-12-11
2025-12-05
Company data provided by crunchbase