- Merck & Co. (Rahway, NJ)
- …Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of… more
- Insmed Incorporated (San Diego, CA)
- …paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, ... be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The… more
- Merck & Co. (Durham, NC)
- …reductions, and standard work at the shop floor level. Collaborates with Operations , Technology and Quality to author regulatory inspection observation responses ... Job DescriptionOur Manufacturing Operations teams are the people that make our...revise Standard Operating Procedures Support of internal and external regulatory inspections, presenting on topics as needed. Day shift… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation ... and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the...and review process in a timely manner as necessary.- Change Control System: Manages an effective … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality, compliance, productivity, yield, and cost.Implement process improvements within the change control system.Recognize and act on potential compliance ... myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR -T Investigation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alternate material sources, alternate BOM/recipes, etc. and collaborate on required change control deliverables where applicable.Provide expert-level support for ... is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewWe are actively seeking a proficient… more
- Merck & Co. (Durham, NC)
- …Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative ... HVAC, and/or multi-stage refrigeration systems) Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations … more
- Merck & Co. (Durham, NC)
- …Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative ... or InstrumentationPreferred 5 years of plant maintenance and familiarity with regulatory requirements in accordance with GMP manufacturing operations Operation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on the platform process description and collaborate to the global change control process and global investigations.RequirementsB.S. required, Ph.D. preferred ... regulatory guidelines, process monitoring and analytics and manufacturing operations support. Ability to think critically and demonstrated troubleshooting and… more
- Merck & Co. (Durham, NC)
- …leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations , Quality and ... member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategies, preventive actionsSupports development of Dx product portfolio under design and change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and ... or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and… more
- Aequor (Thousand Oaks, CA)
- …executive audiences Serving as a Supply Chain resource and/or representative for change control assessments, and special projects and initiatives Working under ... relationships with CMO Supply Chain Team Executing end-to-end supply chain operations such as order and invoice management, shipment management, warehouse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a standard methodology. Oversee applications support groups' system validation and change control process. Develop information system roadmaps.Provide such ... Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on the platform process description and collaborate to the global change control process and global investigations.RequirementsB.S. required, Ph.D. preferred ... knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations … more
- Merck & Co. (Durham, NC)
- …is responsible for leading a team that supports deviation management, change control , site qualification/validation, equipment qualification, and technical ... proceduresDetermine staffing needs and hire to meet those demandsReview and approve Change controls, Quality Risk ManagementServe as the Subject Matter Expert for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Operations and Quality ... report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator-Writer will be responsible for initiating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a GMP Commercial FacilityExperience with Commissioning/Qualification, Asset Change Control , Process/System Improvement, Asset Lifecycle ... reach a solution with relevant stakeholders (eg QA, C&Q, Operations , ). You will develop root cause analyses in...He/she supports CAPAs (Corrective and Preventive Actions) and CCs ( Change Controls) within quality management systems. You will also… more
- Insmed Incorporated (San Diego, CA)
- …batch records, SOPs, raw material specifications, development reports and GMP protocols. Support change control and the change management of different ... for Millennials™, and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you...of MSAT where you will support pipeline programs that change lives. At Insmed Gene Therapy you will be… more
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrate expert knowledge of scale-up principles with respect to viral ... and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission;Must be familiar with BSL-II lab safety requirements;Participate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …verbal) to express complex points to a variety of stakeholders and drive change through persuasion but not organizational power required- 4 or More Years Familiarity ... with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the following: o 21 CRF § 11:… more
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