- Merck & Co. (North Wales, PA)
- …Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality ... Assurance is responsible for independent compliance support of Medical...a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe main functions of the Specialist, Quality Assurance is to assist in the review of batch records, media batch release, investigations, support of ... Quality related audits from external and regulatory agencies .-Identify Continuous Process Improvements to maximize efficiencies and streamline processes within the… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality oversight ... and propose improved objectives as necessary. Deliver methods for risk areas/ process improvement to stakeholders via the...close collaboration with the VP, Global head of Quality Assurance (RD/PV QA). CAPAs Ensure adequate CAPAs are defined,… more
- Eisai, Inc (Nutley, NJ)
- …and data privacy standards. Your responsibilities span security operations, risk assessment, investigations, and compliance issue resolution for the Americas ... CSL, and other relevant Security and Data Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders… 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)
- …to implement `quality by design` within clinical development programs, using a risk -based approach. They will be responsible for the overall strategy for maintaining ... implementation of `quality by design` principles in assigned clinical trials.-Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with… 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC ... skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and imaginative in the… more
- Merck & Co. (Rahway, NJ)
- …concepts.Hands on experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... Microsoft Project or similar package.Active in professional societies.Experience in process improvement.#eligibleforERPBARDS2020SPjobs#EBRG#VETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of change controls, SOPs, and other documentation Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual ... an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance Knowledge of cGMP regulations and FDA/EU… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance , Medical Affairs, Translational ... Oversee applications support groups' system validation and change control process . Develop information system roadmaps.Provide such reports that are required… 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
- Merck & Co. (Rahway, NJ)
- …and alternative solutions.Category management ensuring compliance to the procurement process and supporting the design and implementation of sourcing strategies ... & Utilities are duly signed and stored in time- to ensure the assurance of supply for all company sites.Actively participate in achieving our company's business… 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
- 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
- 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
- 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
