- Legend Biotech USA, Inc. (Raritan, NJ)
- …Revieweras part of the Quality team based in Raritan, NJ. Role OverviewThe QC Data Reviewer is an exempt level position responsible for reviewing all data ... produced by the Quality Control Lab during In-Process and release...of electronic systems (LIMS) for execution and documentation. Create, review , and approve relevant QC documents, SOP's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role ... a controlled cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and WI's.Ensure microbiological control strategy is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control , quality assurance, or cell therapy. A minimum… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is required Experience in a Quality Control setting is preferred.Experience with biosafety cabinets is ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QC Technical Traineras part of the Quality team based in Raritan, NJ.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is requiredExperience in a Quality Control setting is preferredExperience with aseptic processing in ... the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Analyst as part of the Quality team based in Raritan, NJ. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Supervisor, QC Micro as part of the Quality Control team based in Raritan, NJ. Role OverviewThe QC Microbiology ... cGMP facility to manufacture products.Create, review and approve relevant QC documents, SOP's and WI's.Ensure microbiological control strategy is consistent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing process to cGMP facilityCreate, review and approve relevant QC documents, SOP's and WI's5Ensure microbiological control strategy is consistent ... within a biological and/or pharmaceutical industry is requiredExperience in a Quality Control setting is preferredExperience with aseptic processing in… more
- Insmed Incorporated (San Diego, CA)
- …collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, ... daily/weekly/monthly activities of staff and operational oversight of group, data review , schedule, and training.Potentially oversee QC technicians and directly… more
- Aequor (Bothell, WA)
- Job Description: POSITION SUMMARY: Method Transfer Lead (MTL), Scientist, is a QC expert within the Development QC group. This individual contributor has good ... transfer and/or validation internally and externally for assigned program(s). Author or review protocols and reports for method transfer and/or method validation or… more
- Aequor (Tallahassee, FL)
- … QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Lead development and ... oversight of all case intake processing activities and case quality including analysis and reporting of trends in ...their role Support the analysis and communication of case QC results Lead development and delivery of training materials… more
- Insmed Incorporated (San Diego, CA)
- …Change Control and CAPA/Effectiveness Checks. Provide expert QA review , collaboration, and direction for laboratory investigations.Apply Quality Risk ... QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also...analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid… more
- BioAgilytix (Durham, NC)
- …and sample analysisResponsible for prompt identification, submission, notification, and review of deviationsDesign and run assay run independentlyAnalyze, interpret, ... presenting data, updating timeline, and notifying issues Prepare and review scientific training materialsTrain analysts/junior scientistsAssist with definition of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Data Management, and Non-clinical Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials and regulatory ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Relationships: Ability to interact with all levels within the organization. Operations, Quality , HSE, Supply Chain, Warehouse, Training, QC , EM, Operations ... proper materials, parts and spare parts are identified and availablePerforms work review , approval and close out of work orders, including management of third-party… more
- Merck & Co. (Rahway, NJ)
- …the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge ... of the organization and participates in regulatory and other quality and compliance report-outs; review audit outcomes...with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control … more
- Precoat Metals (Washington, MO)
- …activities to ensure continuous control over materials, facilities, and products. Review Trial Order Forms and plans quality activities for all product ... and reliability expectancy of the finished product. Formulates and maintains quality control objectives and coordinates objectives with SOPs to maximize… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, ... you ready to realize your potential? The Position This position will review manufacturing and support documentation and records to certify compliance with in-house… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission and compliance of all required DS documentation for quality control /assurance, legal, finance, operational and educational requirements.Operates ... OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to OLT submission. This position acts as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR). Review and ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by...Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal… more
