- Revolution Medicines (Redwood City, CA)
- …will be responsible for conducting quality audits, vendor compliance with regulations of GxP vendors providing regulated GxP services and products to RevMed. ... and Compliance.Design, develop and implement an internal/external audit schedule for GxP vendors aligned with RevMed SOPs, and global regulatory requirements.… more
- IQVIA, Inc. (Durham, NC)
- We are seeking a QA Auditor 2 to join IQVIA Laboratories in Durham, NC in a hybrid position . We hire passionate innovators who drive healthcare forward through ... join us as we transform and accelerate research and development. As a QA Auditor 2, you will be conducting and supporting audits, managing quality issues, hosting… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Senior Staff GMP Internal Auditor involves planning, coordinating, and performing audits across various stages. A comprehensive understanding of USA and EU ... GxP regulations is essential, with a focus on both...device assembly, and serialization operations. As a GMP Internal Auditor , a typical day might include the following: +… more
- IQVIA (Indianapolis, IN)
- We are seeking a **QA Auditor 1** to join Q2 Solutions, IQVIA's laboratory business at **Indianapolis, IN** . We hire passionate innovators who drive healthcare ... electronic quality management system throughout audit lifecycle + Stay current on GXP regulations and contribute to process improvement and QA consulting **What We… more
- IQVIA (Durham, NC)
- We are seeking a **QA Auditor 2** to join IQVIA Laboratories in **Durham, NC in a hybrid position** . We hire passionate innovators who drive healthcare forward ... join us as we transform and accelerate research and development. As a QA Auditor 2, you will be conducting and supporting audits, managing quality issues, hosting… more
- ThermoFisher Scientific (Wilmington, NC)
- …Office **Job Description** Company Name: PPD Development, LP Position Title: QA Auditor Location: 929 North Front Street, Wilmington, NC 28401 Summary of Duties: ... Audits laboratory data for GxP compliance with methods and standard operating procedures and...role. Must have any amount of experience with: Applicable GxP and appropriate regional regulations; Support, review and revise… more
- Fresenius Medical Center (Waltham, MA)
- …No-Limits Mindset and Results Oriented. **PURPOSE AND SCOPE:** Lead Quality Systems Auditor will act as a Subject Matter Expert (SME) in inspection activities ... and experience required (advanced degree preferred) + 3rd party auditor training (eg ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or...13485, ICH Q7/Q10, ISO 14971, ISO 10993, IE 62366, GxP ) required + In-depth knowledge in the interpretation of… more
- Fujifilm (College Station, TX)
- …science-related field with three (3) years industry experience in a GMP / GxP , or a comparable federally regulated environment; OR + Bachelor's degree preferably in ... field with five (5) years of industry experience in a GMP / GxP , or a comparable federally regulated environment; OR + Associate's Degree preferably in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …working with GCP processes and systems is required. + Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits. ... Six Sigma, is preferred. + Certification as a Quality Auditor is preferred. + BA/BS or advanced degree in...their application to cross-functional clinical development. + Proficient in GxP Auditing with a successful track record of leading… more
