- Merck & Co. (Durham, NC)
- …lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project activities ... improvement projects. - Position Responsibilities Could Include: Reporting to the Quality Assurance Organization, will independently manage project assignments.… more
- Novo Nordisk Inc. (Durham, NC)
- …SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes. Relationships Manager, Quality Assurance . Essential Functions ... on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little… more
- Novo Nordisk Inc. (Durham, NC)
- …& QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions Ensure site compliance with Regulations, ... the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required Understanding of quality … more
- Insmed Incorporated (San Diego, CA)
- …effectiveness of the Quality departmentAssist in other quality assurance related activities as agreed with management .Knowledge & Experience7+ years ... similar function.Full understanding of GMP and Gene Therapy manufacturing.Familiarity with Quality Assurance aspects in manufacturing processes of new… more
- Merck & Co. (Durham, NC)
- …learning events, or business support initiatives, as guided or approved by Quality management .Train employees on new or revised processes or procedures.Review ... interprets client and/or customer needs to identify solutions. FUNCTIONAL EXPERTISE: The Quality Specialist will be responsible for comprehensive management of… more
- Repligen (Washington, DC)
- …also work closely with Repligen colleagues including sales account managers, product management , quality assurance , and R&D scientists/engineers to ensure ... CT, PA).ResponsibilitiesWork in coordination with the Repligen sales team and product management to provide pre- and post-sales support to customers for the XCell™… more
- Tris Pharma (Monmouth Junction, NJ)
- …medical writing software and templates (ie, EndNote, Starting Point, etc.)Experience with data management and quality assurance processesWe are a HYBRID work ... research protocol and amendment developmentSupports regulatory submissions by preparing high- quality documents meeting regulatory requirementsStays current with industry standards/advancements… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director, Quality Management Systems plays a pivotal role in ensuring ... establishment and continuous improvement of an effective, compliant and 'fit for purpose' quality management system (QMS) ensuring Formation Bio is in a phase… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ... management principles in the design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryAccountable for supporting and managing the Quality Management System (QMS) in accordance with regulatory requirements ... requirements for the GMP area.Additional responsibilities include:Creating and reviewing Quality Assurance Agreements with contract organizationsManaging a … more
- Tris Pharma (Monmouth Junction, NJ)
- …statistical expertise with high-level strategic collaborationHands on experience with data management , programming and quality assurance processesExperience ... researchers, data managers and other stakeholders to ensure data quality and compliance with regulatory requirementsMentors and trains junior biostatisticians… more
- Twist BioScience (South San Francisco, CA)
- …in product release activities, including reviewing release documentation and providing quality assurance sign-off.Stay up-to-date on the latest cGMP regulations ... manufacturing for functions for validation planning and transfer activities.Collaborates with Quality Management to support change controls activities (eg… more
- Merck & Co. (North Wales, PA)
- …matter expert for functional group processes, systems, and regulations driving disclosure quality assurance and compliance . Actively monitor evolving standards ... the dynamic transparency landscape and apply evidence-based approaches in transforming quality management across the disclosure framework. Assess insights into… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewSupport the Inhalation Team within the QC Department… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …qualification, packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and ... scale-up, process optimization, customer technology transfer activities with project management assistance.Provide SME information on the request for pricing (RFP)… more
- Merck & Co. (Rahway, NJ)
- …with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance , and Regulatory Affairs to drive data excellence ... a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary clinical… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for ... availability for trials. Establish and maintain 'fit for purpose' GMP related quality assurance procedures processes, and documentation to ensure the consistent… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... field RequiredMinimum 3 years experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... coordinating activities with other departments such as manufacturing, Quality Assurance , and R&D.Providing status updates to management and promptly… more
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