- Merck & Co. (Durham, NC)
- …globe.This is a night shift P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all Quality related functions ... actively participating in and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality … more
- Merck & Co. (Millsboro, DE)
- …reliable supply to customers and patients on time, every time, across the globe.The Quality Control (QC) Associate Specialist, with Guidance from the QC Manager, ... ensures product/process quality through the review of GMP documentation ...and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies… more
- Merck & Co. (North Wales, PA)
- …Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... ensure that the testing is sufficient to meet regulatory requirements and quality objectives.Provide input to design and manufacturing documentation including… more
- Aequor (West Greenwich, RI)
- …PHD. Ideally looking for candidates with at least 2 years of an associate degree combined with 2 years of General lab experience/lab background, GDP/GMP experience ... routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and… more
- Aequor (Thousand Oaks, CA)
- …include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent ... perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Scientist - Biologics Potency We are seeking a highly motivated and experienced Associate Principal ... and novel biologics. In our framework of scientific excellence, the associate principal scientist will be an active individual contributor and guide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based ... in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position...approval of standard operating procedures and any other required documentation . Collaborate with functional departments to resolve issues. Perform… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... safe & effective operations while maintaining a high level of focus on Quality . Coordinates with contractors, engineers & other providers as well as internal… more
- Aequor (Thousand Oaks, CA)
- …installation guides, user manuals, and related technical and business process documentation . When creating, updating and enhancing the documentation , adhere ... guidelines, giving consideration to usability and ensuring accuracy, consistency and quality . Maintain data accuracy and perform data analysis for Management reviews… more
- Merck & Co. (Rahway, NJ)
- …conduct with-ICH/GCP and country regulations, policies and procedures, quality standards and-adverse event reporting requirements internally and externally.Acts ... in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates with… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director, ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and… more
- Aequor (Bothell, WA)
- Job Description: The primary focus of the Manufacturing Associate I role will be cellular therapeutic manufacturing at JuMP during process transfers, routine ... JuMP manufacturing operations and (2) completing production assignments with a high quality and timely output. Performing patient process unit operations and support… more
- Merck & Co. (Rahway, NJ)
- …operations, process development activities, compliance investigations/change management, authoring of GMP documentation , and lead other staff in the pilot plant as ... readiness and execution activities. Prepare, review, and/or approve GMP Documentation as appropriate. Author/Approve Standard Operating Guidelines and Procedures.… more
- Eisai, Inc (Nutley, NJ)
- …code produced by vendor partners meets high standards in terms of quality , documentation , to standards, efficiency, and maintainability.Responsible for ensuring ... ensure digital data is ingested, processed, and delivered with high quality to dashboards, right next engagement platforms, and self-service analytics consumers.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation ... leader, however is also accountable to the VP of quality . The incumbent is expected to understand and apply...for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.- Involve and… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a CAR-T Warehouse Operations Associate as part of the Technical Operations team based in Piscataway, NJ. The ... CAR-T Warehouse Operations Associate will be part of the Technical Operations team...individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions about packaging, methods,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This position has primary responsibility to support operations for Quality Control at our biologics manufacturing facility. Assists in coordination and ... process and equipment improvement programs, creates technical reports, reviews completed quality records, generates quality comment and deviation responses and… more
- Merck & Co. (Rahway, NJ)
- …department of our Research Laboratory Division is seeking applicants for an Associate Principal Scientist position within the Automation group, available at its ... Rahway, New Jersey research facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked with identifying, developing and deploying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation .Establishes Processes and Best Practices: Reinforces labeling ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
