- Bristol Myers Squibb (Indianapolis, IN)
- …the audit program. + Evaluate compliance with applicable regulatory requirements (eg, FDA , EMA, ICH), internal SOPs, and quality agreements. + Document audit ... and industry standards. This role supports the continuous improvement of RayzeBio's Quality Management System and ensures readiness for regulatory inspections… more
- United Therapeutics (Research Triangle Park, NC)
- …manage and prioritize workloads, stressful situations, and deadlines + Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ... Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits. +...12+ years of experience in quality assurance, quality engineering and management in the FDA … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Practice) compliance + Ethics and Compliance + Pharmacovigilance + Partner with Quality , Regulatory , R&D, Manufacturing, Supply Chain, and IT to ensure ... GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, ... intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC… more
- Endo International (Rochester, MI)
- …4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, ... May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.… more
- Actalent (Richmond, VA)
- Quality Test Technician Job Description The Quality Control Technician will play a vital role in ensuring the production of high- quality pharmaceutical ... This position is pivotal in maintaining compliance with cGMP standards and FDA regulations, ensuring product integrity in a dynamic and innovative environment. The… more
- Medtronic (Warsaw, IN)
- …Management System (QMS), ensuring all CAPA activities meet internal standards and FDA /ISO regulatory requirements. The CAPA Specialist will monitor the ... Medtronic's Warsaw, IN manufacturing site, you will be integral to ensuring the quality and safety of our spinal implant and brain/ENT instrument components. You… more
- System One (Piscataway, NJ)
- …support laboratory investigations, deviations, OOS results, and CAPAs + Participate in Quality Events and regulatory inspections (eg, PAI) + Collaborate with ... Job Title: Quality Control Analyst II/III Location: Piscataway, NJ (Onsite:...and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical… more
- Nature's Bakery (Salt Lake City, UT)
- … and Food Safety across functional teams within the facility. + Implements quality assurance programs in compliance with regulatory standards, internal processes ... **This is a role to support our Quality Assurance teams supporting our food manufacturing** Noon...FSMA certifications preferred. + Depth of audit experience with regulatory bodies ( FDA /USDA), consumer audits (Walmart, Costco)… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to ensure compliance with GMP regulations, safety guidelines, and quality standards ( FDA , USP, NRC, EP, and other regulatory agencies as needed). + Weekend ... ensure data trending are executed in compliance with regulations, and company quality standards, troubleshooting efforts, ensuring compliance with regulatory and… more