- Merck & Co. (Rahway, NJ)
- …findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities ... API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)...such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator,… more
- Insmed Incorporated (San Diego, CA)
- … support and coaching to other staff members to develop additional quality and auditing resources.Manage quality documentation in Veeva. (SOPs, ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Aequor (Thousand Oaks, CA)
- …within Quality Control at the Thousand Oaks site and to directly support both manufacturing and Quality Control operations. Under minimal supervision analyze ... the lab, checking to ensure removal of expired media performed, archiving documentation , preliminary plate readings etc. Support Microbiology lab with analytical… more
- Aequor (Thousand Oaks, CA)
- …perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions ... experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T manufacturing site.Oversee metrics, trending, and reporting of relevant quality systems records. Support CAPA site governance programDrive continuous ... Practices (cGMP).Manage multiple and complex cross-functional projects with many stakeholders. Support other quality systems activities, as needed. Support… more
- Aequor (West Greenwich, RI)
- …following activities: 1. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring. 2. Perform testing and possible ... routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …teams Support facility certification for new Manufacturing (process equipment & facility- support equipment) and Quality Control facilities as needed as well ... the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) Performs all job duties and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team responsible for the production of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in line with company-wide policy and relevant regulatory requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for ... function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This… more
- Merck & Co. (Rahway, NJ)
- …action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with ... (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support , ensuring facility, utilities and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile… more
- Eisai, Inc (Exton, PA)
- …may be added at the company's discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, ... pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to… more
- Eisai, Inc (Raleigh, NC)
- …batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.Maintain associated documentation and records ... Records (MBRs)Assist with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation , and reporting… more
- Twist BioScience (South San Francisco, CA)
- …implement robust reporting, analytics, and data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation: ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Eisai, Inc (Nutley, NJ)
- …eTMF internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the ... to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up,...to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices. Act as central point… more
- Merck & Co. (Rahway, NJ)
- …qualification documentation , calibration documentation , computer system inventories Support internal and external quality audits and maintain laboratory ... of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global AR&D network. The role oversees and… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, ... Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media,… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... rather than days. Over time, the same foundation you build will support dashboards, predictive analytics, and other data-driven tools that boost lab productivity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develop publication plans, drive the execution of publication projects, and support other GMA Oncology activities as needed for their assigned ... organizations, and study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start ... family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition… more
