• Catalent (Manassas, VA)
    food safety and quality audits. Participate in customer, 3rd party and regulatory audits. Ensure compliance to the food safety and quality management system ... HACCP, and SQF Demonstrated leadership in the areas of food safety and plant regulatory affairs; Strong organizations and leadership skills; ability to analyze… more
    HireLifeScience (04/09/24)
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  • Perrigo (Eau Claire, WI)
    …submit an application for this open position.) Thank you. Description Overview The Food Safety Specialist maintains pre-requisite programs to ensure Food Safety ... trends and verification activities related to pre-requisite programs. Ensure risk assessments, and Food Safety Management Systems are up to date. Acts as a key team… more
    JobGet (04/24/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify, evaluate and ... and external stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists… more
    HireLifeScience (04/05/24)
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  • Merck & Co. (Rahway, NJ)
    …collectively to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, ... site, region and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance… more
    HireLifeScience (04/16/24)
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  • Catalent (San Diego, CA)
    …Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary ... Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of audit activities… more
    HireLifeScience (04/10/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, etc. ... phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintains… more
    HireLifeScience (04/25/24)
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  • Catalent (Manassas, VA)
    …Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.Shift: 2nd ... numbering, and organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans, and any other documents as required.Manage… more
    HireLifeScience (04/16/24)
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  • Merck & Co. (Rahway, NJ)
    …to support domestic and international registration of pharmaceuticals in food producing animalsUse quantitative and/or qualitative chromatographic techniques, in ... of US-FDA and EU-CVMP guidelines on veterinary drug development for food producing animalsProficient in written communications and in the preparation of… more
    HireLifeScience (04/18/24)
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  • Sutter Health (Sunnyvale, CA)
    …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and ... doctors' orders, lab results, billing, and documentation to meet regulatory standards/requirements.* Obtains a working knowledge of drug identification, medication… more
    JobGet (04/25/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
    HireLifeScience (04/13/24)
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  • Sutter Health (San Francisco, CA)
    …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and ... billing, pricing, record keeping, and provision of services required to meet regulatory requirements.* Maintains records of drug distribution, works with vendors to… more
    JobGet (04/25/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
    HireLifeScience (04/11/24)
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  • Catalent (Philadelphia, PA)
    …that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish ... but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American,… more
    HireLifeScience (04/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International ... process in evaluating study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
    HireLifeScience (03/09/24)
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  • Sutter Health (San Francisco, CA)
    …pricing, record keeping and provision of services required to meet regulatory requirements.*Maintains records of drug distribution, works with vendors to requisition ... the state board of pharmacy, the drug enforcement administration, and the food and drug administration by assisting Pharmacists in monitoring nursing unit… more
    JobGet (04/25/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …or skills needed and/or licenses or certificates preferred:Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) ... guidelines, cGMPs and SOPs regulatory rules, regulations and guidelinesProficiency with Empower software and other laboratory softwareExperience with wet chemistry… more
    HireLifeScience (04/23/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …skills needed and/or licenses or certificates required Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, ... SOPs and regulatory rules, regulations and guidelines Hands on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical… more
    HireLifeScience (04/19/24)
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  • Merck & Co. (North Wales, PA)
    …risks.-Specific areas of responsibility include, but are not limited to: Food , Drug, and Cosmetics Act complianceAdvertising and promotionProduct labelingClinical ... in support of business and research activitiesRelated liability and regulatory issues Position Qualifications: Education Minimum Requirement: Graduate of an… more
    HireLifeScience (04/12/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The ... not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or… more
    HireLifeScience (04/02/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job ... Responsibilities: Perform duties associated with the compounding of various commercial and research drug products and formulationsComplete Pre-Line compounding ActivitiesExecute compounding responsibilities (mixer batch, tank batch, & partner batch)Document… more
    HireLifeScience (03/13/24)
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