- Catalent (Philadelphia, PA)
- …patient and employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer ... Quality Assurance Document Control Supervisor Position...records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Creative Financial Staffing (Columbus, OH)
- …systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing regarding ... in place to support effective program implementation and ensure the quality of financial reporting both internally and externally. Position Responsibilities:… more
- Catalent (St. Petersburg, FL)
- …manufacturing challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department… more
- Merck & Co. (Rahway, NJ)
- …Life Cycle deliverables and testing.Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality ... of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management.As required, participate in Regulatory Agency… more
- Catalent (Harman, WV)
- …First culture at the site. The Head of Quality -Maryland is responsible for Quality , Validation and Quality Control and is the most responsible person ... Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures is performed on manufactured products.Review and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight… more
- American Honda Motor Co Inc (Marysville, OH)
- …America. AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest ... Honda and affiliated company operations which includes the evaluation of control practices, risk management and compliance conditionsDevelop recommendations for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Insmed Incorporated (Bridgewater, NJ)
- …years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, ... or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and support… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Merck & Co. (Rahway, NJ)
- …CRAs on process/study requirements and performs co-monitoring-visits where appropriate.Could perform Quality control visits if delegated by other roles and ... audits/inspections-and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and-escalates per defined CRA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... product profile to ensure appropriate management review of all quality and compliance related topics including the...business process owners to demonstrate that processes are in control and ensure required compliance levels. Implement… more
- Catalent (Philadelphia, PA)
- …guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality ... and effective quality system that delivers reliable, high- quality products that meet all customer and regulatory...have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... Mass Spec equipment, supporting Bulk Chemical equipment, implementations of process change control , Delta V Network and troubleshooting in compliance with system… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and 10 Essentials in all activities and interactions with others Support other quality compliance and implementation projects, as assigned Other Duties as ... a key player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization. Relationships Reports to:… more
- Merck & Co. (Durham, NC)
- …environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world.With our core principle of Safety… more
- Catalent (St. Petersburg, FL)
- …areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the area/site. Will ... experience as QA in pharmaceutical industries. Prior experience working with quality control , manufacturing, product development preferred (Feasibility Batches,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
