- 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 ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... full-time position: Monday - Friday, days. Catalent is a global , high-growth, public company and a leading partner for...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Insmed Incorporated (Bridgewater, NJ)
- …regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure they ... in other departments to increase the overall effectiveness of the Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... and manufacturing equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software for logging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global ... global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all...lead a small project teamBasic knowledge of the Quality System Model and relationships across its componentsUnderstands … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Brazil to ensure relevant quality reports QQRs and or assigned by VP Global Quality Assurance (RD/PVQA) delivered in a timely manner.Ensure that safety ... PV QA strategy in close collaboration with the VP, Global head of Quality Assurance ... lead an efficient and effective organizationSupport the global quality annual objectives, strategic initiatives to… more
- Eisai, Inc (Nutley, NJ)
- …Data Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders across regions in Compliance, ... incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of… more
- Eisai, Inc (NJ)
- …relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to internal ... teams on vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development through supplier… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance:-Develop and implement protocols and ... workload, and ensure the lab maintains a high standard of quality and accuracy.Digital Forensics Investigations:-Conduct and oversee complex digital forensic… 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 cell ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will… more
- Catalent (San Diego, CA)
- …and compliance.Collaborate with other departments to troubleshoot technical issues.Collaborate with Quality Assurance and Quality Control on analytical ... studies to determine if methods are suitable for transfer to Quality Control.Communicate results both internally and externally through oral and written… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of ... are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product...to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a… more
- Bank of America (Charlotte, NC)
- Quality Assurance Lead for Global Regulatory Reporting - US Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common ... structure for the LOB. This role aligns to the Global Regulatory Reporting (GRR) Team within the CFO ...Regulatory authorities. Primary responsibility for this role is to lead the Quality Assurance (QA)… more
