- 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
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... comprehensive, relevant resources (eg training program, FAQs) to enable compliance to change control process requirements across...which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control … 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
- 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
- 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
- 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … with industry regulations and guidelines Content Deployment: Ensure quality control of marketing content in alignment with compliance prior to dissemination ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Aequor (Melville, LA)
- …effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Plant, and Corporate quality and Safety ... pulls from protocol requirements, pull samples and submits to Quality Control Laboratory. Prepare sample labels and...all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA,… more
- Aequor (Hicksville, OH)
- …Performance Monitoring Knowledge of CAPA Technical Launch & Transfer Data analytics Quality Change Control .Keep assigned lines supplied with bulk products and ... all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA,...is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory … more
