- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Quality Systems groups to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and its GMP vendors.Supports Supply Chain ... assure that all newly selected vendors are operating in compliance with the applicable quality program and...are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …discipline is required A minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 of those ... of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …clearancesMaintain gowning qualification for access to aseptic manufacturing areas Perform Quality Assurance compliance review of manufacturing, maintenance, ... activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good… more
- Catalent (Philadelphia, PA)
- … Quality Disposition, Materials Sampling Quality Assurance , Regulatory and Compliance Quality Assurance , and Validation Quality Assurance . ... quality initiatives of processes and programs to assess compliance with regulations, Global and Site SOPs, and client...or equivalent experience. 15 + years of Scientific or Quality Assurance in clinical trials packaging, in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... indicating data and identifying trends Provide oversight for trending of quality compliance metrics Work in a collaborative team setting with quality … more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... shooting and resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance with applicable… more
- Aequor (Thousand Oaks, CA)
- …they are supporting Can rotate every 6 months This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight ... compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance , clinical quality , or ... seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The...is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the ... intern in the field of pharmaceutical Quality Assurance focused on the activities related to the overseeing of manufacturing and distribution activities of… more
- Catalent (Philadelphia, PA)
- …in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent… more
- Aequor (West Greenwich, RI)
- …for the right applicants? Academic background in Sciences, and experience working in Quality Assurance in either Biotech or Pharmaceutical industry. What is your ... Quality Control and Facilities & Engineering staff in regards to compliance and quality systems. Intake Notes: How is the shift schedule decided upon each… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent… more
- Volunteers of America Ohio-Indiana (Columbus, OH)
- …and in the community. Knowledge of, and experience with, accreditation and quality assurance /improvement is required. We Embrace Equity, Diversity and Inclusion ... including, but not limited to, program development and enhancement, quality improvement activities, staff management, asset management, budgeting, and ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance Knowledge of cGMP ... outside contractors/vendors to complete tasks Supports and/or owns technical and quality investigations, CAPAs and corrections Develops and performs any required… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …deviations, CAPAs, and/or managing change controls in the Veeva Digital system. The Quality Systems specialist will support GMP activities to ensure compliance ... approving CAPAs in Veeva.Write/update SOPs and other documentation pertaining to Quality SystemsPotential participation in health authority, 3rd party, and internal… more
- Aequor (Thousand Oaks, CA)
- …understanding of regulatory requirements, safety guidelines and factors impacting compliance ? Demonstrates understanding of when and how to appropriately escalate.? ... May identify, recommend and implement improvements related to routine job functions.? Must learn and comply with safety guideline and cGMPs. more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Catalent (St. Petersburg, FL)
- …in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. ... Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site.… more
