- Repligen (Waltham, MA)
- …critical issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in ... 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey. Role...conducted to support manufacturing to ensure sterility of the product /process is not compromised.Support batch review & material release… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities for direct materials in support of a rapidly expanding, commercialized CAR-T product portfolio. This position will be reporting to Head of Global Sourcing ... sourcing for assigned direct materials category for a fast-growing commercialized CAR-T product .Develop a long-term category strategy aligned with product growth… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... treatment of multiple myeloma.Legend Biotech is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Analyst is an exempt level… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance,… more
- Repligen (Baltimore, MD)
- …will also work closely with Repligen colleagues including sales account managers, product management, quality assurance , and R&D scientists/engineers to ... a US- based Field Application Scientist to technically support the upstream product lines in the bioprocess industry. This individual will use their knowledge… more
- Merck & Co. (Rahway, NJ)
- …closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). Act as subject matter expert (SME) across various franchises and… more
- Merck & Co. (North Wales, PA)
- … product lifecycle for the assigned projects. Assure deliverable quality and process compliance.Responsible for effective deliverable development utilizing global ... team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.].Support Sourcing & Procurement team on implementing supplier performance metrics [e.g. Assurance of Supply, Quality , Service, Cost & Innovation] and ... purchase order listing, un-invoiced receipt amounts, supplier documentation and statements.Monitor product life cycles and alert appropriate team members to any… more
- Twist BioScience (South San Francisco, CA)
- …field or equivalent work experienceBetween 2-4 years of relevant industrial experience in quality assurance .Knowledge of quality standards (ISO 9001, ISO ... QA Associate to join our Operations Team. The QA Associate will perform finished product inspection and assist with shipping. This role may also involve incoming raw… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... a healthier world to live in.Job OverviewServe as technical expert on Quality Control instrumentation and methods. Train and mentor junior chemists. Troubleshoot… more
- Merck & Co. (Rahway, NJ)
- …various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools. Validate and implement… more
- Merck & Co. (Rahway, NJ)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Merck & Co. (North Wales, PA)
- …stakeholder requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... ensuring that project plans are executed efficiently with timely and high- quality deliverables.For assigned projects the position serves as the statistical… more
- Merck & Co. (Rahway, NJ)
- …Operations Support, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies . Once...Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... compliant program to enable robust production, testing and release of product to patients.Key Responsibilities Works with above plant functions to successfully… more
