- Merck & Co. (Rahway, NJ)
- …knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Merck & Co. (Rahway, NJ)
- …controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and evaluationSelf-motivated and work independentlyProven ability to work with team members of… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... components/finished goods. Performs packaging line assignment maintaining line throughput and quality standards. Contributes to the team by supporting other lines… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate quality … more
- Aequor (Hicksville, OH)
- …occur. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... to service multiple packaging lines simultaneously. Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Eisai, Inc (Raleigh, NC)
- …investigation and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality systems.Strong oral and written ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and ... collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Developing quality and strategic objectives and strong business understanding of… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA … more
- Twist BioScience (South San Francisco, CA)
- …across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The ... software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as...MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …global 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will ... range from employee engagement, safe behavior, quality performance (right first time), schedule adherence, and productivity improvements.Support manufacturing… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition ... expedite receipt of incoming product through customs and the FDA . The position is also required to work closely...The position is also required to work closely with Quality Control to make sure that the process flows… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal ... system audit.Support reporting of quality metrics for audits and inspections and execute against...external customers on GxP related regulations / guidelines (eg, FDA , EU, ICH) and company procedures and policies. Competencies:Professional… more
- Tris Pharma (Monmouth Junction, NJ)
- …and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including ... Executes studies and prepares technical protocols/reports in response to FDA Information Requests (IRs)/Complete Response Letters (CRLs)Cleans, maintains and… more
- Merck & Co. (North Wales, PA)
- …preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with regulatory ... agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written...or supporting direct interactions with major Health Authorities (eg, FDA , EMA).Demonstrated success in managing regulatory filings across global… more
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