- BioLife Plasma Services (Trenton, NJ)
- …management. Gain exposure to real-world challenges such as audit processes, compliance requirements, and team performance management. + **Production Environment & ... service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee Relations… more
- Bristol Myers Squibb (Summit, NJ)
- …plans for hazardous materials, potent compounds, and high-containment processes. + Ensure compliance with OSHA, ACGIH, NIOSH, FDA , and other applicable health ... is critical in ensuring workplace safety, employee health protection, and compliance with regulatory standards. The ideal candidate will have comprehensive… more
- Bristol Myers Squibb (Summit, NJ)
- …Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards. + Independent ownership of all lifecycle ... being met. + Ensure equipment, facilities and programs are maintained in compliance . **Knowledge & Skills:** + Excellent understanding of cGXP requirements and good… more
- Actalent (Ledgewood, NJ)
- …aseptic filling, inspection, and labeling/packaging on the floor. You will ensure compliance with cleaning requirements and oversee all quality aspects on the floor, ... filling, inspection, and labeling/packaging on the production floor. + Ensure compliance with cleaning requirements and monitor cleaning activities. + Review and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal ... are met for product development schedules, and checks that technical and compliance requirements are met. + Evaluates, recommends, and implements new analytical… more
- Actalent (Basking Ridge, NJ)
- …procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling regulations and ... to internal procedures. + Coordinate labeling projects to ensure regulatory compliance . + Provide guidance on labeling regulations and process requirements. +… more
- Sumitomo Pharma (Trenton, NJ)
- …cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First" ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Sumitomo Pharma (Trenton, NJ)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Sanofi Group (Morristown, NJ)
- …degree of reliability and users satisfaction + Ensure desired configuration, compliance , business process, data integrity, quality, validation, security and system ... team of Data Base experts + Critical data analysis skills (systems/processes/ compliance ). + Teamwork and interpersonal skills + Organizational and planning… more
- Ascendis Pharma (Princeton, NJ)
- …Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local ... in development. . Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections… more