- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the ... will allow them to dive into different functions of GMP QA Department such as Audit, Quality Management System,...into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.Additional Supported AreasAs… more
- Merck & Co. (Durham, NC)
- …Experience and f amiliarity of regulatory requirements in accordance with GMP manufacturing operations Preferred Education and Experience: Five years of plant ... Electrical or InstrumentationExperience working in a clean room or GMP /regulated manufacturing environmentOperation, maintenance and/or troubleshooting experience with automated… more
- Catalent (San Diego, CA)
- …with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as ... established deadlines for completion of review and corrections;Reviews and approves GMP product labels;Support GMP manufacturing activities including release of… more
- Merck & Co. (Rahway, NJ)
- …product design from the bench top to the Good Manufacturing Practice ( GMP ) manufacturing facilities, our Scientists use cutting-edge science to transform drug ... of continuous learning and improvement, scientific and operational excellence, safety, GMP and compliance mindset, and collaboration with various partners and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process development, as well as oversight… more
- Catalent (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... activities accordingly in the associated logbook(s). Reviews production logbooks for GMP compliance. Reviews and understands both the Production Protocol and QA… more
- Merck & Co. (Rahway, NJ)
- …Research Laboratories, our company's Manufacturing Division, Animal Health and GWES. The system is GMP and monitors areas and equipment that are both GMP and ... and the ability to understand, update and implement changes to the GMP system.Ability to problem solve/troubleshoot, with knowledge of root cause analysis.Experience… more
- Merck & Co. (North Wales, PA)
- …seamless integration and realize synergies where available while ensuring compliance to GMP requirements.- Ensure alignment to corporate policies as well as other ... governance forums.Ensure continuous improvement to New Modalities QMS to maintain GMP and Regulatory compliance.Stay ahead of current GMP requirements… more
- Merck & Co. (Durham, NC)
- …activities are carried out in accordance with established safety, GMP , and calibration/maintenance procedures.Facilitates contractors by obtaining bids, review ... refrigeration systems).Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.Willing and able to lift 50 pounds, climb… more
- Merck & Co. (Durham, NC)
- …reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.Assisting in the development and review and approval of ... department SOPs and other site GMP SOPs related to automation and digital activities and...and troubleshooting in compliance with system life cycle (SLC), GMP , Data integrity, safety, and environmental regulations. Provides client… more
- Catalent (Harman, WV)
- …department investigation writers. Administers the CAPA Tracking System for general GMP use and internal audits while tracking completion of commitmentsPerform ... manufacturing campaignsMaintain databases and systems used for tracking various GMP manufacturing associated support activitiesAssist with the generation and/or… more
- Merck & Co. (Durham, NC)
- …lyophilizers, etc.).Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule ... AM - 2:30 PM EST. (May include weekends and holidays)Preferred Experience and Skills: GMP quality experience with biological drug substance or drug product. GMP … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities ... experience. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a… more
- Catalent (San Diego, CA)
- …with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as ... established deadlines for completion of review and corrections. Reviews and approves GMP product labels.Support GMP manufacturing activities including release of… more
- Merck & Co. (Durham, NC)
- …execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdownsCoordinates activities with ... maintenance activities are completed in accordance with established safety, GMP , and calibration/maintenance procedures.Monitor KPIs (MTTR, MTBF, Uptime) and ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …quality professional in ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage GMP development ... programMinimum of 2 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …co-lead the deviation investigations management system. Ensure alignment with GMP regulations and organizational objectives in all investigation activities. ... including minimum of 3 years in deviation investigations management within a GMP -regulated environment. Strong understanding of GMP regulations, root cause… more
- Merck & Co. (Durham, NC)
- …and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safetyTactical ... degree and two (2) years of experience in a direct GMP , biotechnology, manufacturing setting.Required Experience and Skills:Demonstrated ability to lead a… more
