- Novo Nordisk Inc. (West Lebanon, IN)
- …FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and support for all phases of Clinical and ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance , Finance, R&D, Project Management ... Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and… more
- Merck & Co. (Rahway, NJ)
- …procedures.Prepare the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance , Medical Affairs, ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Merck & Co. (Durham, NC)
- …experienceAseptic Gowning knowledge and techniquePrevious shop floor quality , quality control or quality assurance experienceExperience with ... assignments to support business needs. Primary Responsibilities: Member of the Quality Sterility Assurance team, providing support to ensure compliance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …zero defect manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This ... to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance, Cost of Quality , Validation on Time. Job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... Quality ).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …microbiological and manufacturing process nonconformances.Assist Sterility Assurance and Quality management during routine audits by regulatory agencies, ... is expected to coordinate project execution and to work alongside Sterility Assurance , Quality , and Operations personnel to ensure execution. The primary… more
- Insmed Incorporated (San Diego, CA)
- …clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring the ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Merck & Co. (Durham, NC)
- …Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.The Senior Specialist, Quality Assurance ... with strategic direction facilitated by our global business model and regulatory compliance.--General Profile:Investigation of Product Quality Complaints and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management, operations and/or ... Quality , NNI IT and Telephony, Medical Information, Compliance, Regulatory , Legal and Privacy. External relationships include Patient Support program vendors… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or ComplianceExperience conducting internal ... part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions… more
- Merck & Co. (Durham, NC)
- …work at the shop floor level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes ... support critical project initiatives at the site, support the ongoing sterility assurance program, and be involved in developing and implementing corrective actions.… more
- BioAgilytix (Durham, NC)
- …you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance (QA) audits, inspections (internal/external), and monitoring ... role/operations Not less than two (2) years' experience in GLP/GCLP quality assurance (QA)Experience working in biotech, pharmaceutical, CRO/CMO or… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... myeloma.Legend Biotech is seeking QA Investigations Supervisor as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Supervisor has… more
- Genmab (Plainsboro, NJ)
- …areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance , Clinical Strategy, and other stakeholders.Address drug supply ... be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural… more
- AUROBINDO (Dayton, OH)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to ... or related scientific discipline.Up to 2 years experience in pharmaceuticals Quality control Laboratory. Physical RequirementsLAB TECHNICIANS - Must be able to… more
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