- 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)
- …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
- 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology, analytics, and ... reporting initiatives across the NovoCare® Patient Affordability and Access Support Platform. Oversight, maintenance, and ongoing enhancements related to the Patient… 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
- 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
- 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
- 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
- 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
- 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
- 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 night shift ... Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media,… more
- Merck & Co. (Durham, NC)
- …Maintenance Processes, Manufacturing Operations, Manufacturing Processes, Operations Support , Pharmaceutical Production, Pharmaceutical Quality Assurance, ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… 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
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start ... an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory...The Receiving Supervisor must ensure that all the appropriate documentation has been provided to APUSA and submit the… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a QC Inspector I to join our growing Quality Department team in Hopkinton, MA for 2nd shift operations (M-F).The QC Inspector I will report ... position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for inspecting, auditing and reporting… more
- Merck & Co. (Rahway, NJ)
- …requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as ... Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines...supply chain documentation to support critical CMC activities. -… more
