- Sotera Health Services, LLC (Itasca, IL)
- …compliance for Nelson Labs. Department processes include function support, internal audits, external audits, agreements, change management, failure investigations ... agency interactions. The Regulatory Specialist is primarily responsible for executing internal and external audit processes. The Regulatory Specialist acts as the… more
- HiFyve (Minneapolis, MN)
- …identify root causes and evaluate effectiveness of corrective actions. Collaborate with internal teams and customers to define and monitor key quality metrics. ... Update and author SOPs; perform internal audits and support quality training efforts. Ensure compliance with cGMP, FDA, ISO 9001, safety, and environmental… 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 ... primary packaging and labeling, device assembly, and serialization operations. As a GMP Internal Auditor , a typical day might include the following: +… more
- Integra LifeSciences (Plainsboro, NJ)
- …Coordinate, conduct (as lead or contributing auditor ), and provide follow-up for internal audits and/or assessments of all GMP /GLP related site activities. + ... pathways to advance patient outcomes and set new standards of care. The ** Internal Auditor , Regulatory Compliance** will have an in-depth understanding 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 ... the global QS audit program + Lead and manage internal and corporate audit program for all assigned sites,...and experience required (advanced degree preferred) + 3rd party auditor training (eg ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Principal Auditor , Audit & Compliance provides leadership, direction and performs comprehensive ... Their leadership, direction, and execution in the area of GMP compliance and quality assures that activities are performed...effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates… more
- Graphic Packaging International, LLC (Groveport, OH)
- Quality Assurance Tester/ Auditor Requisition ID: 7002 Location: Groveport, OH, US, 43125 Department: Hourly Plant & Mill (Except Maintenance Roles) Travel: No Travel ... Important: Smoke/Tobacco Free Facility **Position Description: Quality Assurance Tester ( Auditor ** ) This position is responsible for ensuring consistent quality… more
- Trane Technologies (Noblesville, IN)
- …challenge what's possible for a sustainable world. **Job Summary：** The Quality Auditor : . Promotes Helmer values as demonstrated in personal productivity and ... quality of work, management of internal /external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Quality Lead, GMP , GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We deliver 4.3 ... product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines. Internal and External Auditing and Regulatory Inspections. + Covers an international… more
- Teva Pharmaceuticals (Davie, FL)
- Quality Assurance Auditor I Date: Jul 5, 2025 Location: Davie, United States, Florida, 33326 Company: Teva Pharmaceuticals Job Id: 61820 **Who we are** Together, ... opportunity** This position is responsible for leading and maintaining the site Internal Audit Program and providing support during business partner audits and… more
- Kayem Foods, Inc. (Chelsea, MA)
- …company standards, customer specifications, and regulatory requirements (USDA, HACCP, BRC, GMP , SSOP). + Conduct internal audits and pre-operational inspections ... preferred. + Working knowledge of USDA, HACCP, BRC, SSOP, and GMP standards. + Internal or external auditing experience required (BRC certification a strong… more
- Indorama Ventures (Port Neches, TX)
- …7 years of experience in Quality Assurance + Lead ISO9001 Auditor + Internal Auditor of GMP /GDP/ GFSI Certification (BRC, FSSC 22000, EXCiPACT, RC14001, ... System. This role promotes preventive actions to meet regulatory standards (HARCP, GMP 's, ISO 9001, EFFCI, among others) and monitors non-conformances arising from… more
- Hologic (Marlborough, MA)
- Director, Internal Audit Marlborough, MA, United States Are you a seasoned quality and compliance professional with a passion for driving excellence in regulated ... environments? We're looking for a **Director, Internal Audit** to join our team and play a...global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated industries such as medical devices… more
- Fujifilm (College Station, TX)
- …into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of ... management to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. + Mentor peers… more
- Abbott (Casa Grande, AZ)
- …and enhance the lives of millions worldwide. **What You'll Work On** + Performs internal audits as Lead Auditor and guides external audits of various Governments ... manages the documentation system, systems for food safety and laboratory quality, internal and external audit programs, pest control and sanitation program and… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …relating to the verification programs. + Conducts audits and/or coordinates with USP GMP auditors at USP Rockville and at USP international sites to provide ... necessary assistance to enable the auditor (s) to conduct a thorough audit of program participants' manufacturing facilities for the manufacture of drug substances,… more
- LGC Group (Petaluma, CA)
- …you will support the Quality Assurance function at our brand new therapeutic GMP oligonucleotide facility. You will collaborate with various GMP functions to ... QMS, Technical Complaints, and QA reporting. + Quality Operations: Maintain GMP compliance and inspection readiness across the organization. + Investigations:… more
- Berry Global (Valdosta, GA)
- …audits and onsite visits. Communicates key quality information to appropriate internal personnel. + Develops an annual Quality Improvement Plan. Executes and ... quality systems, processes, procedures in accordance with current Good Manufacturing Practices ( GMP ). + Develops and maintains test methods to meet inspection needs.… more
- Catalent Pharma Solutions (Harmans, MD)
- …timely resolution + Responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension ... a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation + Bachelor's degree in a Scientific, Engineering or Biotech field… more
- AbbVie (North Chicago, IL)
- …future opportunities. Qualifications Purpose The function of Audit and Compliance Senior Auditor /Lead is to performs comprehensive audits for compliance with US and ... products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed...effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates… more
