- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions ( Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, ... ensure proper service levels, and assess ability to meet quality and delivery requirements. + Establish, manage, and control...and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc. + Monitor the new… more
- Merck (Rahway, NJ)
- …(our Manufacturing Division/our Research & Development Division) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression ... is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in… more
- Integra LifeSciences (Plainsboro, NJ)
- …Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive. ... Submit samples for shipment to third-party labs when necessary. + Maintain GMP /GLP laboratory notebooks and documentation relevant to the duties and responsibilities… more
- Bristol Myers Squibb (Summit, NJ)
- …Cell Therapy team. The QA Shop Floor Specialist is responsible for quality oversight of Manufacturing Operations in accordance with Bristol-Myers Squibb policies, ... **Responsibilities:** + Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to… more
- Terumo Medical Corporation (Somerset, NJ)
- …functionality + Perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of...drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of… more
- Integra LifeSciences (Plainsboro, NJ)
- …of critical analytical and process instrumentation and control loops used in GMP processes at the Integra Collagen Manufacturing Center (CMC). The Sr. Analytical ... Technician ensures that all calibration activities protect the identity, quality , durability, reliability, safety, and effectiveness of medical devices and,… more
- Sokol Materials & Services (Skillman, NJ)
- …or its equivalent is preferred. QUALIFICATIONS: + Advanced Level of relevant experience in a GMP , GCP, or GXP with at least 8 years focused on product quality . ... integrity principles + Proven attention to details + Comfortable working in an FDA regulated environment. About the Role DUTIES AND RESPONSIBILITIES: * Provide QA… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners ... issues; Escalates to senior leadership as needed . Partners with Quality Assurance to resolve quality -related issues with labels/labeling/distribution vendors… more
- Bristol Myers Squibb (Warren, NJ)
- …projects to completion, and owns project summary reports. **Technical and Quality Responsibilities** + Understand new technologies, introduced to the Manufacturing ... and Quality Control areas, and serves as the first line...discipline. + Minimum of 5 years of experience in FDA -regulated industry (validation preferred), or 3 years and an… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and implementation of cross-functional action plans, in close collaboration with Quality , R&D, Supply Chain, and Commercial teams. + Drive continuous improvement ... tools, and data-driven insights to optimize turnaround times and service quality . + Facilitate expert-to-expert communication across global and local teams, ensuring… more