• Catalent (Manassas, VA)
    …Verifying Food Safety Plans and Pre- requisite programs. Lead and supports plant audit programs in ensuring that compliance and plant SOPs are followed. Ensures all ... products produced meet or exceed all customer, regulatory and company requirements as they relate to food safety. Enforces the company's food safety standards as outlined in the plants FSP, and GMP standards and other programs. Develops staff through… more
    HireLifeScience (03/13/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …during regulatory agency inspections and vendor audits.Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities ... Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs.CQA representative for… more
    HireLifeScience (03/12/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …tasks.Develop the performance/talent of direct reports.Schedule, staff, train, and audit multiple activities for responsibilities.Ensure completion of all testing, ... important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status efforts for assigned areas and participate in internal… more
    HireLifeScience (03/21/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to dive into different functions of GMP QA Department such as Audit , Quality Management System, Pharma Product, External Supplier Management and Strategical ... for local SOP's and SOI's.Support Quality personnel as part of audit activities of manufacturing, facility, and quality controls areas and operations.Review… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Durham, NC)
    …to better / best practices & projects for manufacturing compliance & robustness Audit team coordination & development of audit standards / practices Owner ... of procedural support for Bulk processes, Pas-X, & other systems as required Follow all safety and environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33… more
    HireLifeScience (03/06/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …immune disorders.Job Summary:The Compliance Intern will provide support to the Internal Audit function as well as provide other project support to the ... Training and Monitoring and investigations teams. Under the direction of the Audit function, this position will perform compliance, financial, and operational audits… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in support of a proactive quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to ... the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality) and in close collaboration… more
    HireLifeScience (02/24/24)
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  • Catalent (St. Petersburg, FL)
    …drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.Change Control, as it pertains to ... regulatory audits.Engage in monitoring quality systems to maintain awareness and audit /inspection readiness at all times.Ability to investigate and analyze technical… more
    HireLifeScience (02/23/24)
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  • Eisai, Inc (NJ)
    …in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to internal audits and corrective ... minimum 7 years pharmaceutical/clinical outsourcing.In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal, written and… more
    HireLifeScience (02/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within… more
    HireLifeScience (03/28/24)
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  • Novo Nordisk Inc. (Ocala, FL)
    …of regional resources to ensure attainment of profitability goals Review and audit expense reports Continuously improve the knowledge of Novo Nordisk products, ... competitive products, and management skills through ongoing home study and participation in company sponsored/approved training programs Execute regional level account targeting strategy in business unit to fulfill regional account targeting strategy… more
    HireLifeScience (03/27/24)
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  • Catalent (Philadelphia, PA)
    …the facility as requested and ensure the department areas are clean and audit /tour ready.Other duties as assigned. The Candidate High school diploma or general ... education diploma is required. Bachelor of Science degree (or equivalent work experience) is preferred. Minimum 4 years distribution experience and previous supervisory experience in union environment is preferred. Excellent interpersonal and communication… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …and Pharmaceutical Operations.Support internal and external compliance audit activities.Education Minimum Requirements:Advanced and relevant industry experience ... for applicants with a Bachelor of Science degree, or beginner, relevant industry experience for applicants with a Master of Science degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences.Required Experience and SkillsExcellent written and oral… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …Committee and/or Executive TeamPartner with global security, IT disaster recovery, internal audit , and other risk and resiliency related teams to deliver a unified ... program ensuring visibility and communication.Develop and foster relationships across the internal network with key functions including teams in facilities, human resources, safety and the environment, and others to ensure robust response and recovery… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …cleaning studies, facility validation, computer validation, temperature mapping, audit support, CAPA, validation deviations, commission activities, change requests, ... deviation investigation & writing. Support validation activities associated with changes to existing & new systems. Process equipment includes synthesizer, deprotection systems, UF/DF, chromatography skids, glasswashers, buffer preparations systems, annealing… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …with the Quality & Standards team as appropriate to understand and address audit & inspection findings that impact processes and systems-Creates a culture of ... innovation. Seeks and assesses internal and external innovations and drives the execution of transformational and innovative solutions-- Builds solid working relations across the Company organization to ensure that all areas (eg, Enterprise, Commercial,… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …applications teams from Novo Nordisk (NN), IT security teams from NN; Legal, audit and compliance representatives from NN; NNI IT group for infrastructure, network, ... security, application, and user related activities. External stakeholders include service providers for support of scientific instruments and systems. Essential Functions Provides technology support and service: Develops strategies and processes to ensure that… more
    HireLifeScience (03/21/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …and migrations Proactively monitors AEM solution to ensure compliance with SOP, audit , security and industry best practices Stay current with AEM platform updates, ... new features, and industry best practices, and provide recommendations for platform enhancements Physical Requirements 10-20% overnight travel required. Qualifications Bachelor's degree in Computer Science, Information Systems, Business Administration or other… more
    HireLifeScience (03/20/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …AEM implementations Proactively monitors AEM solution to ensure compliance with SOP, audit , security and industry best practices Stay current with AEM platform ... updates, new features, and industry best practices, and provide recommendations for platform enhancements Mentor and coach junior AEM developers, contributing to their professional growth and skill development Physical Requirements 10-20% overnight travel… more
    HireLifeScience (03/20/24)
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