- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.Coordinate and ... rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …departments to resolve issues.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality… more
- Merck & Co. (Durham, NC)
- …(SME) during tours to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance- Foster strong safety culture ... order to resolve process/equipment issues, minimize downtime, and ensure product quality .--This role will support manufacturing activities at the Durham Site.… more
- Aequor (East Syracuse, NY)
- …issues, if applicable. Identify opportunities for workflow and procedural improvements. Promote quality , safety , and health, by ensuring clean work area, and ... Knowledge/Skills: Knowledge of aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures preferred. Has excellent manual… more
- Repligen (Clifton Park, NY)
- …timely delivery and stakeholder alignment.Oversee contractors/vendors and ensure compliance with safety , quality , and operational standards.Support quality ... role manages preventive maintenance programs, equipment optimization, vendor coordination, and quality support, while serving as a technical subject matter expert… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …other applicable acceptance criteria.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review and approve ... Biotech is seeking Principal QA Validation Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe Principal QA Validation Specialist… more
- Tris Pharma (Monmouth Junction, NJ)
- …maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety , quality , and regulatory standards in warehouse operationsManages, ... Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company… more
- Aequor (Piscataway, NJ)
- …to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs.5. Implement ... solutions and help leading decisions to resolveManage and deliver assignments with quality and within timelines by being independ and proactive4. Solid Statistical… more
- Merck & Co. (Rahway, NJ)
- …manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good ... pharmaceutical ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design of… more
- Merck & Co. (Rahway, NJ)
- …and ensure that all platforms (eg syringes, auto injectors, bottles, blisters) meet safety , efficacy, quality , and robust supply standards. Drive proactive risk ... packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …teams to ensure that all platforms (eg syringes, auto injectors, kits) meet safety , efficacy, quality , and robust supply standards. Develop and maintain strong ... sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) ... serves as a strategic leader managing quality and regulatory compliance related to GCPs,...observations and development of adverse trends) to ensure patient safety and data integrity.Supports strategic direction with cross functional… more
- Aequor (Fort Worth, TX)
- Job Description: Ensure that lab cleanliness and safety standards are maintained. Develop and qualify new testing methods. Train other analysts to perform laboratory ... recommendations regarding their use. Serve as a technical liaison between quality control and other departments, vendors, or contractors. Coordinate testing with… more
- Aequor (Fort Worth, TX)
- Job Description: Job title: Associate I, Quality Control Lab - Microbiology Location: Fort Worth, TX (Onsite) Duration: 12 months Interviews: 2Job Description:Years ... for production. Conducts and analyzes in-process and final product quality analyses/inspection in compliance with standards and regulatory requirements Identifies… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams and stakeholders to ensure that all platforms meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory, manufacturing, and Supply Chain to facilitate… more
- Merck & Co. (Rahway, NJ)
- …that all solutions (eg thermal containers, package designs, new components) meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory, manufacturing, Device Development and Technology, to… more
- Aequor (Thousand Oaks, CA)
- …/ or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance ... ? Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/data according to company and regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a clear, concise format.Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with ... Manufacturing, Warehouse, Engineering, and Quality , and work as part of a cross-functional team to complete production tasks required by shift schedule.Support the… more
- Aequor (Thousand Oaks, CA)
- …/ or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance ... Qualifications Ability to adhere to regulatory requirements, written procedures and safety guidelines Ability to evaluate documentation/data according to company and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …confined space entry programs, facility emergency response plans and other required safety programs. Supports Quality driven initiatives related to facilities ... team that supports daily production of a CAR-T manufacturing facility.Maintains safety standards and training in the department; ensures that the building… more
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