- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... risk management principles in design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and… more
- Merck & Co. (Rahway, NJ)
- …and our company's requirements while driving continuous improvement in Device Supplier Quality Management .- Accountable for other Quality Programs, as ... 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the Quality Manual.Previous experience in Medical… more
- Genmab (NJ)
- …we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical Data ... vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of EDC systems,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to quality standards in ongoing projects and processes.Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including ... that enhance the skills and capabilities of team members in quality management .Foster a culture of continuous learning and professional development within the… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Regulatory Compliance, Policy Development, Process Facilitation, Process Improvements, Quality Improvement Programs, Quality Management , ... Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed… more
- Merck & Co. (Durham, NC)
- …learning events, or business support initiatives, as guided or approved by Quality management .Train employees on new or revised processes or procedures.Review ... compliance guidance to employees, colleagues or clients.FUNCTIONAL EXPERTISE:The Associate Quality Specialist will be responsible for comprehensive management … more
- Aequor (Thousand Oaks, CA)
- …of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems. ... approved by management . 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project life cycle. 5.… more
- Pall (Miami, FL)
- …on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and ... Pall is there, helping protect critical operating assets, improve product quality , minimize emissions and waste, and safeguard health. For the exponentially… more
- BioAgilytix (Durham, NC)
- …skillsProficiency in MS Excel and WordProficiency in LIMS and Quality Management software packagesAdditional ResponsibilitiesOther duties as neededMinimum ... to quickly build proficiency in MS Excel, MS Word, LIMS and Quality Management softwarePreferred CredentialsExperience with shipping and receiving procedures… more
- Cepheid (Miami, FL)
- …Auditor to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to ... waiting.Learn about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations ... for the oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...laboratory data management , LNR collection standards, and quality issue management .- Collaborates with laboratory DM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Merck & Co. (Rahway, NJ)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Budget Management , Clinical Operations, Clinical Quality ... with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional Operations Teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigation strategies and process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review Board) across the global ... remediation and risk management in close collaboration with the organization's quality management system, to assure robust knowledge transfer and continuous… more
- Merck & Co. (Rahway, NJ)
- …and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems. Qualifications: EducationRequired - Technical BS degree or ... design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. Exceptional project … more
- Merck & Co. (Rahway, NJ)
- …combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems, and industry best practices.Exceptional strategic ... role is accountable for ensuring each inline team has robust lifecycle- management plans, appropriate and rigorous technical support processes to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within a matrixed global teams environmentMust have a broad understanding of quality management system, GxP regulations and industry trend/practiceMust have ... SummaryThis role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to use &/or update relational databases required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred ... quality system, including knowledge of FDA requirements preferred Strong project management capabilities to guide the creation of high- quality SOPs aligned… more
- Repligen (Waltham, MA)
- …MA site.This position is responsible to actively participate in the Repligen ISO 9001 Quality Management SystemThis is a full-time on-site role in Waltham, MA ... years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. Microbiology experience required.Knowledge and experience… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key… more
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