- Novo Nordisk Inc. (Plainsboro, NJ)
- …assure accurate and complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with input on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… 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. ... in the treatment of multiple myeloma. Legend Biotech is seeking an Investigations Supervisor as part of the Technical Operations team based in Raritan, New Jersey.… more
- Nesco Resource (Dublin, OH)
- …quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirementsRead and/or understand operating procedures for specific products ... finished goods to appropriate locationThis position is required to assure compliance of Company operations to all applicable laws, regulations and standards,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement ... testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with career development, performance and other… more
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... QA Supervisor Position Summary Catalent Pharma Solutions in Philadelphia,...Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …activities, work orders and projects to ensure proper working order and compliance of systems with cGMP's. Assists with preparation of yearly Facilities budget, ... training is maintained at or greater than 90% Provide input during regulatory inspections Maintain facilities documentation compliant with current regulatory … 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 management ... services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor will lead Food Safety and Quality programs. This includes… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance , accuracy and timeliness of testing processes in compliance ... (SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined practices… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Facility Supervisor as part of the Maintenance & Metrology team based in Raritan, NJ. ... Role Overview The CAR-T Facility Supervisor is an exempt level position working within Technical...in accordance with all cGMP, company policies, and appropriate regulatory standards. Performs work review, approval and close out… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. ... Role Overview The QA Investigations Supervisor has the responsibilities for providing quality oversight over the production of a personalized cell therapy to support… more
- Penske Truck Leasing Co., LP (Columbus, OH)
- …identify and correct unsafe conditions, work processes, and behaviors * Ensure compliance with all applicable regulatory agencies, company policies and ... district and other equipment vendors * Other projects and tasks as assigned by supervisor Qualifications: * 4 - 6 years related functional experience. * 3+ years… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …adherence to cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines. Relationships Reports to: According ... applicable department equipment and techniques related to job function, and regulatory requirements for the operation of the area Support evaluation, specification,… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... plans and contributes to the development of group strategiesPriorities based on compliance , departmental budget and profit plan to address resource and operational… more
- George Washington University (Washington, DC)
- …research matters in areas of oversight; maintain staff productivity; and resolve compliance , service and operational issues. The Director, Regulatory Oversight ... compliance with ethical and legal business practices and accreditation/ regulatory /government regulations.Responsibilities Provides strategic leadership and operational direction to… more
- Merck & Co. (Durham, NC)
- …(7pm - 7am) on a rotating 2-2-3 schedule.AccountabilityFirst line operations supervisor with a team of individual contributor production direct reports including ... product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Merck & Co. (Durham, NC)
- …to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively ... (QNs), and other key automation-related processesProviding direct support for regulatory inspections and audits and other validation activities by serving… more
- Merck & Co. (Durham, NC)
- …safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching ... of the team (eg documentation, housekeeping, area 5S, etc.)Participate in safety/ regulatory audits (ie tours, topic discussion)FinancialCoach the team to ensure SAP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the ... process in evaluating study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Perform ... attention to detail using cGMP techniquesReport process deviations to supervisor to prevent product deviationsAssist with materials management, inventory, logging… more
