GMP Auditor, Med Device (Ex-FDA Preferred)
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. Onsite audit in San Diego, CA Early March, 2026 30-hours Rate + Expenses 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 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
Nice To Haves
- Ex-FDA Preferred
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
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What This Job Offers
Education Level
No Education Listed
