- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its production ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Specialist… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham within the Vaccine ... while actively participating in and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 of those ... in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the...hoc, for activities such as annual product review, site risk register, or internal quality agreements.Develops and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality risk management and support strategic changes to the Quality Management System (QMS) to ensure compliance with GxP regulations and industry ... industry best practices and internal standards as well as managing quality assurance processes and leading continuous improvement initiatives within… 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 ... of lab consumables, as well as interact with Production, Technology, and Quality Assurance as required to support vaccine manufacturing.Primary Responsibilities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance (QA) group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and ... Data Quality will be responsible for the quality / compliance , remediation, support, and quality ...in a multi-cultural environment. Partner with our company IT Risk Management organization and our primary customers / business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... Audit and Compliance QA function to develop compliance and risk criteria, in order to...in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research… more
- American Honda Motor Co Inc (Marysville, OH)
- …Audit assists operational management with analysis of their operations from a compliance , controls, efficiency and risk management viewpoint. The primary role ... suppliers and vendors, which includes the evaluation of control practices, risk management and compliance conditions Develop recommendations for improving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities, timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliance of all required DS documentation for quality control/ assurance , legal, finance, operational and educational requirements.Operates at ... DS to ensure compliance and alignment with DS highest standards. Uses quality improvement techniques to increase the quality of all OEDC work.Engages in… more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data… 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 , ... and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported… more
- Merck & Co. (Rahway, NJ)
- …lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance , (2) effective deliverable development utilizing global ... and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years of professional experience within the pharmaceutical industry working within Quality Assurance is required.Must have a broad understanding of ... R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and act as the US QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance , Medical ... systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company… more
- Merck & Co. (North Wales, PA)
- …requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting ... data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn… more
- Aequor (Seattle, WA)
- …standards and company policies. 2. Deviation Management: Collaborate with laboratory staff, quality assurance , and regulatory affairs teams to document and ... Conduct thorough impact assessments for deviations reported, ensuring that risk is evaluated and documented effectively. Facilitate cross-functional meetings to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Candidate must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... by ensuring inspection readiness within facility.Provide oversight for trending of quality compliance metrics.RequirementsA minimum of a Bachelor's Degree 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 , ... trouble shooting and resolving complex scientific / technical problemsDevelops and evaluates quality processes and system standards to ensure compliance with… more
