- Repligen (Waltham, MA)
- …technical field. 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO ... issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality… more
- Merck & Co. (Rahway, NJ)
- …Process, Mechanical Apptitude, Operations Support, Pharmaceutical Development, Pharmaceutical Manufacturing , Pharmaceutical Quality Assurance , Process ... molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. The y will… more
- AUROBINDO (Dayton, OH)
- …quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing , R&D, Quality Assurance and Quality control and ... history of excelling in generic pharmaceutical product development and manufacturing . Aurolife has a 10 year history of extraordinary.... Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The… more
- AUROBINDO (Dayton, OH)
- …quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing , R&D, Quality Assurance and Quality control and ... has a long history of excelling in generic pharmaceutical prouct development and manufacturing . Aurolife has a 10 year history of extraordinary manufacturing … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing ... Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or equivalent industry experienceMust have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , ... site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.Review of all documentation, in accordance with Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, and Analytical/Process Development.Job ... is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: As a member of the Company's Research Laboratories Quality Assurance community, provide for and lead Quality ... tailored approaches for computer system validation activities and testing.Provide independent Quality Assurance oversight for the implementation of new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing ... to work independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support,… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the ... knowledge in medical device engineering, particularly in the design, manufacturing , and regulatory aspects of Autoinjectors and combination products.Primary… 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 ... procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing /Supply Chain environment, strong analytical and advanced Excel skills with the… more
- Merck & Co. (Rahway, NJ)
- …various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... manage deliverables to progress the pipeline. - Responsibilities Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process… more
- Merck & Co. (Rahway, NJ)
- …closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... support release and stability testing of clinical materials. Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing… more
- Merck & Co. (Philadelphia, PA)
- …Report, Audits Compliance, Communication, Compliance Remediation, Customer Satisfaction, Data Quality Assurance , Document Control Systems, Electronic Common ... Technical Document (eCTD), Employee Training Programs, Leadership, Management Process, Manufacturing Quality Control, Organizational Performance Management, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sheet development, and negotiate contracts.Lead cross-functional teams and collaborate with Quality , Legal, CMC, MSAT, Manufacturing , Supply Chain, and ... and execute a long-term category strategy supporting ongoing and future manufacturing efforts such as process automation.Key Responsibilities Lead global sourcing… more
- Merck & Co. (Rahway, NJ)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit… 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 ... ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast-paced startup environment.What You'll Be Doing Assist with writing… 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 ... methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit… more
- Merck & Co. (North Wales, PA)
- …team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess ... in ensuring that project plans are executed efficiently with timely and high- quality deliverables.Serve as the statistical programming point of contact and knowledge… more
