- Actalent (Indianapolis, IN)
- …corrective actions. Essential Skills + Quality Assurance + Audit + Regulatory Compliance + GXP + GMP Manufacturing + ISO Certified Auditor + Risk Management + ... **IMMEDIATE OPENING: Sr. QA Regulatory Compliance Auditor ** Candidate must be able to interview onsite...testing and bioanalysis services as a Lead QA Compliance Auditor within the Quality Assurance team. This role focuses… 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
- ThermoFisher Scientific (Richmond, VA)
- …and quality to deliver groundbreaking innovations. **Discover Impactful Work** Become a QA Auditor II at Thermo Fisher Scientific Inc. and join a team committed to ... these issues. + Perform technical document reviews and other GxP activities in support of project work or company...develop solutions. + Experience in technical document review and GxP activities. + Strong communication skills for reporting and… 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
- J&J Family of Companies (Raritan, NJ)
- …maintains assessment tools for the qualification and validation of conveyed IT GxP systems + Applies comprehensive risk management approaches and Quality and ... and design issues + Strong experience in computer systems validation in GxP environments in the pharmaceutical industry required + Advanced proficiency in Quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …experience working with GVP processes and systems is required. + Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. + ... such as Lean Six Sigma, is preferred. + Certification as a Quality Auditor is preferred. **Knowledge & Other Preferred Requirements** + Expert knowledge of the… 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
- Medtronic (Minneapolis, MN)
- …and Regulatory Frameworks including Fair model, CIS, NIST, ISO, SOX, GxP , CCPA, GDPR, PCI Compliance. + Industry-recognized certifications, including Certified ... (CISSP), Certified Information Security Manager (CISM), Certified ISO Lead Auditor , Certified Information Security Auditor (CISA) strongly preferred.… more