- Actalent (Cranbury, NJ)
- …method development. Technical Knowledge & Skills + Strong understanding of cGMP, FDA guidelines, and pharmaceutical quality control standards. + Hands-on ... Quality Control (QC) Chemist - Interviews Happening This...SOPs. + Support environmental monitoring and ensure compliance with FDA regulations. + Collaborate with senior personnel for troubleshooting… more
- Merck (Rahway, NJ)
- …human health. **Responsibilities:** The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key… more
- BeOne Medicines (Pennington, NJ)
- …flow, depth, viral and dead-end filtration, buffer preparation, and product quality analysis. Key duties involve leading data analysis, authoring protocols and ... in inspections. + Collaborate closely with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development… more
- ZOLL Medical Corporation (Parsippany, NJ)
- …company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we ... Hospitals, emergency medical services (EMS), and others trust us to provide high- quality products and exceptional customer service. ZOLL products are used every day… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …through nextGen portals is a plus. + Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. + Independently manage preparation ... local and/or global functional units [OPCJ CMC RA, Factory, Quality , MPDD, OPDC/OPEL Tech Ops] as well as affiliates,...investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda +… more
- Abbott (Princeton, NJ)
- …and formats a wide variety of technical documents. + Collaborates with software and hardware engineering, operations, quality , and regulatory affairs, among ... location has an opportunity for a **Technical Writer** in the Instrument Operations Software technical group within **Abbott Point of Care** (APOC). Our Point of… more
- J&J Family of Companies (Titusville, NJ)
- …Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, ... the clinical team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol development, execution of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities. ... with GRA department to execute departmental initiatives to improve overall efficiency, quality , and/or output. - Assess and develop innovative ideas to move GRA… more
- System One (Park Ridge, NJ)
- …of scientific documents under minimal supervision to meet or exceed quality standards. + Drafts eCTD written and tabulated summaries, investigator brochure ... content, FDA briefing packages, and other agency related technical documents,...teams. + Leads the compilation, writing, and editing of high- quality module 3 documents in collaboration with SMEs (material… more
- BeOne Medicines (Pennington, NJ)
- …This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development ... of drug preclinical, clinical, and commercial requirements. + Familiarity with FDA regulatory requirements for submissions. + Effective communication, oral and… more