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GMP Auditor, Med Device (Ex-FDA Preferred)

Remote, USA Full-time Posted 2026-07-28
For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, reputed company & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company 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 • reputed company + Expenses • SOPs/QMS documents in reputed company • reputed company 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 reputed company 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 reputed company; includes preparation & delivery We celebrate our differences and reputed company to create a workplace where reputed company person can be their reputed company self. We are committed to diversity, equity, and inclusion. Employees are encouraged to reputed company their innovative, reputed company, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a reputed company reputed company where reputed company feel empowered to succeed. reputed company applications to roles at reputed company 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 reputed company supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based reputed company a reasonably short commute of one of our offices to work on a hybrid reputed company and spend some time working from that office location, as agreed with your manager. reputed company applications will be treated on their own reputed company and candidates will not be at any advantage or disadvantage based on their proximity to an office. • **reputed company does not accept unsolicited resumes from recruiters/reputed company parties. Please, no phone calls or emails to anyone regarding this posting.*** Apply tot his job Apply To this Job

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