- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise 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. Role OverviewThe Quality Systems Lead role is an exempt level position with...an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy… more
- Insmed Incorporated (San Diego, CA)
- …they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA)… more
- Aequor (Thousand Oaks, CA)
- …Engineering areas/staff in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic ... documentation and operations according to company procedures. Experience working with Quality Systems , Strong organizational skills and ability to manage… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance...skills Experience with GxP systems including computer system validation and associated regulations, recommended.… 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 ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Repligen (Waltham, MA)
- …analysis and corrective action methodologies. Proficiency in conducting risk assessments and quality audits. Experience with eQMS systems or digital audit tools ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… more
- Eisai, Inc (Raleigh, NC)
- ….Familiarity with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical ... verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project management… 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 ... the most likely cause of the deviation investigation Knowledge Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating… more
- Aequor (Walkersville, MD)
- …for finishing activities Assisting in reviewing paperwork and logbooks for the department Quality Responsibility Maintenance of quality systems and cGMP ... compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Safety Responsibility Is knowledgeable and complies with all pertinent safety policies, rules… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... at the site, including Planning, Procurement, Manufacturing, Distribution, Engineering, Quality and Customer Service Order Processing.Hire Operations leadership team.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 development of… more
- Twist BioScience (South San Francisco, CA)
- …to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems .Superior interpersonal skills and ability to develop ... will have an opportunity to help shape the team's systems and processes as we continue to scale with...ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale and team commitments to goals… more
- Twist BioScience (South San Francisco, CA)
- …including Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems ... (eQMS) Experience with Google Suite and/or MS Office Products required. Experience with Master Control, Atlassian Confluence and/or JIRA preferred. Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential,… more
- BioAgilytix (San Diego, CA)
- The Laboratory Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate ... ResponsibilitiesParticipates in implementation planning, qualification and/or validation of laboratory systems and softwareAuthors and reviews validation deliverables (risk assessment,… 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
- Aequor (West Greenwich, RI)
- …Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory ... equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines,… more
