- 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
- Merck & Co. (Rahway, NJ)
- …and external stakeholders to support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance:-Develop ... and in compliance with legal and regulatory requirements. Manage and provide technical guidance to a team of digital forensics analysts, assign and prioritize… more
- Aequor (Thousand Oaks, CA)
- …4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. ... such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical… 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...for proper resolution to ensure product qualityPROJECT MANAGEMENT:Accountable for quality and/or technical contribution to project team… more
- Insmed Incorporated (Bridgewater, NJ)
- …with trouble shooting their complaints.Job Requirements:Minimum of 5 years of relevant Quality Assurance experience in Engineering, Life Science, or related ... OverviewThe Senior Quality Engineer at Insmed position reports directly to...for prevention of reoccurrence. Tracks and identifies trends of quality events, including Complaints/Deviation/CAPA/EC.Serves as a technical … more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior… 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 ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Manager role as part of the ...of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is required. A minimum… more
- Catalent (St. Petersburg, FL)
- …to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for...highest integrity, in partnership with Catalent St. Petersburg's internal technical departments. This position is expected to serve as… more
- Merck & Co. (Rahway, NJ)
- …leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and ... Maintains productive communications with staff, colleagues across CMC development, Quality Assurance , and CMC Regulatory Affairs as needed… more
- Catalent (St. Petersburg, FL)
- …site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited ... Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site.… more
- Merck & Co. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... technology team, responsible for development/ governance/ operations of the enterprise-wide technical SAP ERP asset. Their responsibility includes DEV/OPS for SAP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , MSAT or ... front line support to address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical … more
- Aequor (Devers, TX)
- …preferred. Minimum 4 years relevant work experience, with experience in a Quality Assurance role. QUALIFICATIONS REQUIRED Equivalent combination of education and ... and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must… 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)
- …Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance, Quality Assurance , pharma-specific litigation issues, promotional brand ... PII data that is maintained within DSI. Oversees and maintains necessary technical systems to support the company's adherence to data privacy requirements. Ensures… more
- BioAgilytix (Durham, NC)
- …settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge ... you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance Performs ... and write up Deviations events utilizing Root Cause Analysis Utilize the quality system to implement changes associated with technical operations, engineering,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . Essential Functions Responsible for the manufacture ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support to the development team during implementation and participates in testing and quality assurance to ensure compliance with regulatory requirements such as ... to apply/integrate to policies and assists in the development of data migration, integration, and quality projects based on business needs. Provides guidance and… 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" ... process.Responsible for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material… more
