- Merck & Co. (Rahway, NJ)
- … Quality Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems , Quality Risk Management, Technical Writing, ... include but are not limited to the following: Perform quality assurance activities related to API manufacturing...documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance… more
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Repligen (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both ... by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and… more
- Aequor (Hicksville, OH)
- …feedback on operator performance. Interacts with production management, mechanics, and Quality Assurance . Participates in training of new employees. Adheres ... to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and… more
