- 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
- 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
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development, ... in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a variety of… 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
- 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
- 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
- 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
- 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
- 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
- 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)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Compunnel (El Segundo, CA)
- …or Engineering discipline, or equivalent experience in manufacturing with a focus on quality . Knowledge of FDA and ISO compliance, including auditing, SOPs, and ... Job Summary We are looking for a Quality Technician I to provide technical support across...in supporting audits, inspections, and testing activities aligned with FDA and ISO compliance. Key Responsibilities Support production teams,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration (DEA), and Occupational Health and Safety ... across organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation ... processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to determine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated ... internal and external customers on GxP related regulations / guidelines (eg, FDA , EU, ICH) and company procedures and policies.International experience including EU… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areasExperience… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition ... would be preferable Knowledge in Good Documentation practices. Knowledge in USP/ICH/ FDA Ability to learn quickly and decision making skillsEducation &… more
