- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized ... with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Cardinal Health (Trenton, NJ)
- …maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key ... IT operations, projects, and M&A activities are aligned with enterprise standards, regulatory requirements and industry's best practices. In this role, you will have… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Ascendis Pharma (Princeton, NJ)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety regulations, ICH ... create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Astrix Technology (New Brunswick, NJ)
- …and clean steam systems operate reliably, efficiently, and in full regulatory compliance to support continuous manufacturing operations. The ideal candidate will ... accurate, compliant documentation in accordance with SOPs, GMP, and FDA regulations. + Collaborate cross-functionally with Facilities, Engineering, and Quality… more
- Hackensack Meridian Health (Perth Amboy, NJ)
- …programs with 12 years BMET work experience. + Demonstrated understanding of FDA , Joint Commission, CMMS, and NJDOH standards. + Demonstrated understanding of ... computerized maintenance management systems + Demonstrated ability to access public FDA 510k information about patient care medical devices. + Demonstrated knowledge… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of… more
- System One (Fairfield, NJ)
- …teams require immediate decisions. Strong 1st-shift QA coverage is essential to maintain FDA , HACCP, GMP, and customer compliance as production ramps up across the ... and incubators + Interpret, document, and communicate microbiological findings Food Safety & Regulatory Compliance + Follow and enforce GMP, HACCP, and FDA food… more
- FreshRealm (Linden, NJ)
- …develop frontline supervisors and hourly staff. + Ensure compliance with USDA, FDA , OSHA, HACCP, GMPs, and facility food safety programs. Represent the manufacturing ... to full production. + Promote and enforce a culture of workplace safety and regulatory compliance. **Skills and** **Requirements** + Familiar with USDA, FDA , and… more
- Stryker (Trenton, NJ)
- …+ Lead and mentor teams to build robust software architecture aligned with regulatory requirements. + Drive development and utilization of tools and systems that ... management. + Knowledge of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971,...820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). 115,600.00 to 245,800.00 salary plus bonus… more