- Merck & Co. (Rahway, NJ)
- …Position Description: As a member of our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for ... Management System elements into the end-to-end computer system validation process , thereby promoting permanent inspection readiness.Develop and maintain a subject… 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 are meeting ... to QC Lab and operationsPartners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active… more
- American Honda Motor Co Inc (Marysville, OH)
- …join our team to Bring the Future!About this Position: The Supplier Process Sr. Engineer position supports supplier delivery and characteristic improvement activity ... Management, as well as New Model, Procurement, and Supplier Assurance to drive supplier characteristic improvement.Responsibilities include:Support supplier improvement… more
- Catalent (St. Petersburg, FL)
- …Method Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer, etc.), Risk Assessment, Formulation ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management… more
- Merck & Co. (Rahway, NJ)
- …holder through the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable ... industry best-practicesExperience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- American Honda Motor Co Inc (Marysville, OH)
- …Future!LocationMarysville, OhioJob PurposeThe AHM Audit Division is an independent, objective assurance and consulting activity designed to add value and improve an ... Board (NAROB) and senior executives across North America to strengthen risk management, internal controls, and governance processes among Honda and affilated… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams, including development, product management, and quality assurance , to ensure the successful delivery of high-quality software ... test metrics to measure the effectiveness of the validation and testing process . Generate regular reports, highlighting test results, defects, and overall quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities, timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with ... issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk -Based Approach/Computer Software Assurance (RBA/CSA) to assure related… more
- CohnReznick LLP (Hartford, CT)
- …do! We currently have an exciting career opportunity for a Tax Manager - Quality Assurance and Risk Management to join the team in our National Tax practice. ... are seeking a highly motivated Tax Manager - Quality Assurance and Risk Management to join our...memoranda and tax alertsAssisting with the tax compliance inspection process , including the preparation of the inspection documentation for… more
- Merck & Co. (North Wales, PA)
- …holder through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable ... industry best-practices.Experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.Additionally, Liaise with Quality Assurance group to obtain QA risk rating and audit status for RDP ... from executed contract; and Update CLM system/trackers throughout the process .- Conduct simple negotiations review contractual amendments details against original… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on the Floor ... hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality, or cell therapy. A minimum of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a cell ... oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a QA R&D Senior ChemistSUMMARY:The Quality Assurance (QA) Research and Development (R&D) Senior Chemist takes a leadership role for ... source qualifications and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Develop and ensure execution of an effective and efficient GOMA CoE Risk Management Plan (RMP) and support conduct oversight. Assess CoE compliance risks ... operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across functions,… more
- Tris Pharma (Monmouth Junction, NJ)
- …2 immediate openings for QA R&D Analytical Chemists, ISUMMARY:The Quality Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control ... source qualifications and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform… more
- American Honda Motor Co Inc (Summerfield, NC)
- …all required training including Team Leader initiated OJT related to SD/QD assurance process development.* Prioritize and balance workload to minimize AHM ... reporting.* Manage activity related to specific top focus suppliers high delivery risk areas. Set priorities with supplier management to implement c/m's & improve… more
- Merck & Co. (Ames, IA)
- …of product to customers, ie International Registration, Quality Control, Quality Assurance , Production, etc.Provide Sales force training as well as guidance on ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Novo Nordisk Inc. (Boulder, CO)
- …& other stakeholders, & presentation in steering groups Support local Quality Assurance unit activities Business Process Improvements: Manage activities of the ... With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality.Strategic thinking - ability to turn… more
