- Merck & Co. (Rahway, NJ)
- …one or more functional areas such as quality assurance , laboratory, manufacturing, production, equipment/facilities management , regulatory. Good ... Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible...include but are not limited to the following: Perform quality assurance activities related to API (including… 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. (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
- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …root cause investigations into microbiological and manufacturing process nonconformances.Assist Sterility Assurance and Quality management during routine ... should be able to work with direction from Sterility Assurance Management to uphold the policies and...to coordinate project execution and to work alongside Sterility Assurance , Quality , and Operations personnel to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs by tracking and following up ... and procedures (system level).Provide guidance, with oversight by RD Quality team members, during the development and...quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of… 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 ... biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team is within our Research & Development Division's Quality Assurance , Global Development Quality organization and is responsible ... Technologies, Global SAP Process Stewardship for our Research and Development Division Quality , Management of...Development Division's IT team as well as multiple Quality Assurance sites and functions within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management , operations and/or other related ... Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance and Program … more
- Twist BioScience (South San Francisco, CA)
- …Engineering, Biomedical or Biological Sciences, or a related field.10+ years of experience in quality assurance or customer service, with at least 5 years of ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...experience in a supervisory or management role.Proven ability to lead and manage projectsStrong analytical… 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 ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes… more
- AUROBINDO (Dayton, OH)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing… more
- Merck & Co. (Rahway, NJ)
- …with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance , and Regulatory Affairs to drive data excellence ... efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of comprehensive… more
- Aequor (Chattanooga, TN)
- …and Microbiology) CHC Research and Development Analytical Research and Development Analytical Quality Assurance Complaints Competencies Must be ... Manager, Quality Dotted Line to: N/A Department: Quality Assurance Location: Chattanooga, TN Job Summary...organized and detail oriented Project management Technical writing Statistical Analysis Ability to adapt to… 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
- 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 ... process.Direct and coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development , technology … 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 ... quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across the organization.This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance , Medical Affairs, ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Twist BioScience (South San Francisco, CA)
- …uncover non-obvious needs.Incorporate quality into product design, and work closely with development and software quality assurance teams on product and ... towards Operational Excellence.Have experience using and/or managing Lab Information Management Systems (LIMS) and Manufacturing Execution Systems (MES).Have strong… 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 ... with a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of extraordinary manufacturing… more
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