- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will ... direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction,...Assurance team on second shift.Lead a Shop Floor QA team to provide end-to-end QA support… more
- Insmed Incorporated (San Diego, CA)
- …with colleagues in other departments to increase the overall effectiveness of the Quality departmentAssist in other quality assurance related activities as ... 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)
- Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance , the Associate Director Quality Engineering & Quality ... (ISO 14971) and other worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with ... investigations, deviation management, and Corrective/Preventative Actions (CAPAs)Previous background in quality control, quality assurance , auditing, or… more
- Merck & Co. (Durham, NC)
- …in pharmaceutical operations, technical operations, validation and/or process Quality Assurance .Required Experience and Skills:Strong Batch Record Review and ... high level/ priority projects, ensuring timely completion.Preferred Experience and Skills: Quality Technical experienceElectronic Batch Records (MES)cGMP experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , quality control, manufacturing compliance, clinical ... Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager… more
- BioAgilytix (Durham, NC)
- …then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance ( QA ) audits, inspections (internal/external), and ... laboratory/bench role/operations Not less than two (2) years' experience in GLP/GCLP quality assurance ( QA )Experience working in biotech, pharmaceutical,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… 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 ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Supervisor as part of the Quality team based in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Specialist (1st shift) role is an exempt level position with responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business ... around rare diseases and immune disorders. JOB SUMMARYThe Associate Director, GMP QA Process Excellence is accountable to collect information, analyze quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product material.Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical ... the treatment of multiple myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the... Batch Warehouse Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... with all CFR, USP, cGMPs, and SOPs. SQE Manager, QA Compliance will rely on experience and judgment to...to plan and accomplish goals specific to the Supplier Quality Program. This position supports the ongoing development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting and participating in regulatory agency inspections, partner audits, and QA inspections preferred- Veeva Quality Docs Vault, Valgenisis, Trackwise ... for process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is… more
- Merck & Co. (Durham, NC)
- Job DescriptionQuality Engineering (QE), part of Durham's Quality Assurance ( QA ) organization, in Building 160 (B160) is seeking a Quality Specialist ... facility environmental requalification activities.- Position Responsibilities :- Report to the Quality Assurance ( QA ) organization, independently support … more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed a new manufacturing facility to significantly expand its ... inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion....of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones. Provide QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and supports oversight and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership,… more
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