- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...analytical skills and report writing skills Experience with GxP systems including computer system validation and associated… more
- Aequor (Thousand Oaks, CA)
- …graduates without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily ... the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Aequor (Thousand Oaks, CA)
- …sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance ... communication skills Time management Proficient computer skills (ie documentation systems , databases and spreadsheets). Bachelor's degree OR Associate's degree and… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell therapy.GxP Quality System knowledge, including ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... ERP systems .Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Aequor (Houston, TX)
- …the most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents ... with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental...cause of the deviation investigation Knowledge Familiarity with cGMP quality systems , and demonstrates ability to read… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, ... Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance, Systems Troubleshooting {+ 3 more}-Preferred Skills:Job Posting End Date:08/1/2025 *A job… more
- Repligen (Hopkinton, IA)
- …experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.Ability to communicate with multiple departments and ... is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for inspecting, auditing and reporting on… more
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role… more
- Twist BioScience (South San Francisco, CA)
- …field2+ years industrial experience in Operations/QCPreferred QualificationsKnowledge of/experience with Quality Control and Quality Assurance principles, ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
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