- Nesco Resource (Columbus, OH)
- …application. Collaborate with the internal teams, Master Data, Operations, Safety, Regulatory Compliance to understand new products and system attributes ... to multitask. JOB DESCRIPTION Contribute to the proper management of product quality complaints and adverse events in accordance with company policies, directives… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory , and business perspectives to ensure compliance with evolving ... closely with Supply Chain Technical Operations teams and Global Regulatory Leads to release high quality labeling...Authority inspections and partner PV audits. Review and ensure compliance with PV Agreements and the regulatory … more
- Catalent (Manassas, VA)
- …for ensuring compliance with FDA and cGMP standards for Quality Control , including continuous training; Responsible for ensuring Dietary Supplement's ... to support continuous improvement efforts; Document all areas of non- compliance with the Quality System and ensure...and track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete,… more
- Russell Tobin & Associates (Dublin, OH)
- …teams ensuring on time, on budget, and with a focus on high- quality delivery while meeting project metrics Maintain and grow client relationships to ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Catalent (San Diego, CA)
- … Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and...committed to a Patient First culture through excellence in quality and compliance , and to the safety… 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
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/ Quality Control function with a strong familiarity ... independently under minimum supervisionAbility to work in fast paced environment supporting the quality assurance/ quality control departments of a CMO for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure product reliability, quality , efficacy, and complianceOversee compliance auditing program to fulfill regulatory requirements.Follow applicable ... manage the departments of Quality Assurance, Sterility Assurance, and Quality Control .Experience Requirements 15+ years of relevant and current work… 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
- 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
- Catalent (Manassas, VA)
- …internal food safety and quality audits. Participate in customer, 3rd party and regulatory audits. Ensure compliance to the food safety and quality ... (SQF) Certification, and its initiatives. This position also requires Quality Control data base management and ...leadership in the areas of food safety and plant regulatory affairs; Strong organizations and leadership skills; ability to… 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
- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …by the engineering department for operations, maintenance, and project delivery. The Quality Engineer will assure that cGMPs and regulatory standards are ... involving engineering activities and audit engineering practices to assure compliance with expectations.Job Responsibilities:The Quality Engineer will be… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …across multiple shifts to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal regulations for current Good ... Investigations, Change Control , and CAPA(s)Work with Area Management to drive Quality Culture Providing Quality Assurance oversight in the Sterile production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …changes/improvement. Partner with all stakeholders to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes. ... Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR). Review… 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)
- … compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk ... will reviews manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
