- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based in Raritan, NJ. ... Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in ... Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, ... NJ. Role Overview The QA Investigations Supervisor has the responsibilities for providing quality oversight...uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug-free workplace… more
- Merck & Co. (Durham, NC)
- …validated state. Provide SME knowledge for manufacturing, utilities and facilities investigations by authoring QNs, support product impact assessments, root cause ... aspects of regulatory inspections by presenting and defending technical documentation, investigations , and change controls Helps to establish empowered teams to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as ... strategic capacity plans and competitiveness (COGs reduction/TAT/OOS reduction), global investigations , global metrics reporting and systems Co-Facilitates complex global… more
- Merck & Co. (Rahway, NJ)
- …to internal and external manufacturing sites, process validation, manufacturing investigations and trend analysis, process enhancements, next generation process ... trends observed in commercial process monitoring and for further technical investigations and process improvement changes.Primary focus will be on downstream… more
- Merck & Co. (Rahway, NJ)
- …pipeline. This role may support facility operations, support compliance investigations /change management, author GMP documentation and manage/lead engineers in any ... drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Familiarity with US and EU GMP and… more
- Merck & Co. (Rahway, NJ)
- …will play a pivotal role in driving seamless technology transfers and conducting investigations as needed for our cutting-edge combination products. Join us and be ... humidity.Conduct aging studies (eg, accelerated and real time) and root cause investigations of drug delivery systems, eg, inhalers, auto injectors, pen injectors,… more
- Merck & Co. (Rahway, NJ)
- …components may include review of batch documentation and deviation investigations .Ensures permanent audit readiness, regulatory inspection support and monitoring, ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical ... technical activities Provide expertise and solutions to issues related to investigations and deviations occurring during routine manufacturing and protocol driven… more
- Merck & Co. (Rahway, NJ)
- …Contractor Liaison function through review and approval contractor related investigations , development of contractor profiles, and contractor CAPA management.The ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (South San Francisco, CA)
- …evaluations, permit recording and review, conducting hazard assessments, incident investigations using root cause analysis techniques, environmental regulatory field ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Rahway, NJ)
- …and scientific presentations to capture development progress, scientific investigations , and technology development outputBasic understanding of statistical methods ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Rahway, NJ)
- …drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Ability to prepare or leverage Standard ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Durham, NC)
- …to team members.Review and approve documents as necessary including investigations , change controls, SOPs, validation protocols, technical reports.Makes decisions ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Lundbeck (Bothell, WA)
- …with QC to ensure successful method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as required Prepare and qualify cell ... the US career site . Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity… more
- Merck & Co. (Austin, TX)
- …environment and independently prioritize work.Handle repetitive issues and investigations or special requestDesired Experience and Skills:-Understanding of Vendor ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Rahway, NJ)
- …(SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management.Familiarity with US and EU GMP and ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Rahway, NJ)
- …Commissioning, Qualification and Validation.Experience in supporting quality investigations and change management.-Working conditions:This position may have ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
- Merck & Co. (Durham, NC)
- …(SOPs) for the performance of Incoming Quality processes.-Supports and contributes to investigations as needed and follows site procedures in the documentation of ... Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace . - All qualified applicants will receive consideration for employment without… more
