- 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 ... 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)
- …treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QC Microbiology Data Reviewer is an exempt level position...cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and WI's.Ensure microbiological control… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, corrections and/or CAPAs.Represent and support Regulatory Inspections for QC .Perform peer review /approval of laboratory data .Utilize ... position with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This… 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)
- …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
- 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, ... activities of staff and operational oversight of group, data review , schedule, and training.Potentially oversee QC technicians and directly manage… more
- Aequor (Bothell, WA)
- …functional reps. Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis ... POSITION SUMMARY: Method Transfer Lead (MTL), Scientist, is a QC expert within the Development QC group....validation internally and externally for assigned program(s). Author or review protocols and reports for method transfer and/or method… 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
- BioAgilytix (Durham, NC)
- … data , updating timeline, and notifying issues Prepare and review scientific training materialsTrain analysts/junior scientistsAssist with definition of project ... and sample analysisResponsible for prompt identification, submission, notification, and review of deviationsDesign and run assay run independentlyAnalyze, interpret,… more
- Merck & Co. (Rahway, NJ)
- …the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge ... SME for EQA; Maintains and provides expertise on EQA quality and/or business systems, tools, data , and...with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …squad. Ensuring compliance with industry regulations and guidelines Content Deployment: Ensure quality control of marketing content in alignment with compliance ... customer experience campaigns and engagement. With guidance of subject matter experts, review and interpret campaign/tactic data to inform adjustments on… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensures all contract exhibits are in the correct format and aligned. Performs overall quality control of the contract. Accountable for the contracting process, ... that the contracts add value to the organization (cost, quality , timelines).Responsibilities- Procurement Manages outsourcing activities including contract budget,...review and approval in accordance with company policies for… 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...develops approach to solutions Ability to work on complex Quality projects where analysis of data requires… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing ... deliver under pressure and time constraints, while maintaining a high level of work quality .Ability to present scientific data and concepts to CMC team members… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …as labeling collection tubes and transporting supplies to appropriate area, quality control review of data , coordinating sample shipment, and acting as ... shift or study lead. Activities as lead may include scheduling team work assignments and acting as primary point of contact for the study director for a particular shift.QualificationsRequires a high school diploma or equivalent and 3-5 years of related… more
