- Merck & Co. (Rahway, NJ)
- …Support compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead ... Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Risk Management , Technical Writing, Test and Evaluation (T&E), Validation… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner… more
- Cepheid (Miami, FL)
- …and applicable US FDA, EU IVDR, and other applicable global standards.Fulfill all quality planning, stability, and risk management deliverables with feedback ... quality systems activities related to assay development, specially design control and risk management activities in accordance with FDA and ISO regulations.… more
- Merck & Co. (Rahway, NJ)
- …manufacturing. -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical ... The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …manufacturing environments.Deep expertise in quality systems and tools, including risk management , CAPA, APQP, PPAP, FAI, and statistical analysis ... to develop long-term supplier partnerships to elevate supplier performance, mitigate risk , and ensure consistent delivery of high- quality metals components… more
- Novo Nordisk Inc. (Durham, NC)
- …SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead in… more
- Repligen (Waltham, MA)
- … quality assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and ... 3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a… more
- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... and release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality … more
- Aequor (Houston, TX)
- …Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple ... deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.… more
- Cytiva (Pensacola, FL)
- …including operational controls, CAPA, complaints, audits, and risk management .Analytical and Process Optimization: Proficiency in quality statistical ... do: Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance,… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring ... about the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of… more
- Merck & Co. (Durham, NC)
- …individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex ... environmental, health, safety, and sustainability (EHS&S) opportunities.- Ensure comprehensive change management of all EHS and Site initiatives to ensure ongoing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision...RBQM activities and deliverables in terms of timeline and quality .- People Management Leadership: Accountable for the… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), ... development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …(8) years combined experiences in commercial/business and manufacturing (operations, project management , or quality , technology, supply chain etc.) function in ... Focus, Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance, Regulatory Compliance {+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal system ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Merck & Co. (Rahway, NJ)
- …E, Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and ... Summary:The Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ecosystem, including card… more
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