• Catalent (Manassas, VA)
    compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications. Regular working hours ... will love. The Quality Manager will l ead Food Safety , and Quality activities on the floor and accountable...Lead and supports plant audit programs in ensuring that compliance and plant SOPs are followed. Ensures all products… more
    HireLifeScience (03/13/24)
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  • Eisai, Inc (Nutley, NJ)
    …for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai ... want to hear from you. Job Summary Manages assigned staff to assure compliance with standard operating procedures, compliance with regulatory standards and… more
    HireLifeScience (03/05/24)
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  • Catalent (St. Petersburg, FL)
    QA Product ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with ... representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
    HireLifeScience (02/23/24)
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  • Catalent (St. Petersburg, FL)
    …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations,… more
    HireLifeScience (02/22/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product ... ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and that … more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Durham, NC)
    … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be… more
    HireLifeScience (03/27/24)
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  • Eisai, Inc (Nutley, NJ)
    …in a dialogue about clinical evidence, approved indication(s), and the product efficacy/ safety profile to support on-label prescribing for appropriate ... the midst of an important launch of a new product in the US focused on educating HCPs on...cross-functionally while adhering to all of Eisai's ethics and compliance standards. Essential Functions Develop and maintain superior clinical… more
    HireLifeScience (03/28/24)
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  • Merck & Co. (Durham, NC)
    …documents) to support project and future operations. - Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while ... detailed knowledge of equipment and processes. - Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …organization inclusive of regional Labeling Strategy groups and Labeling Operations Compliance across the development product portfolio. Oversee the processes ... knowledge of scientific, regulatory, and business perspectives to ensure compliance with evolving global regulatory requirements and with company objectives.… more
    HireLifeScience (02/23/24)
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  • Catalent (Philadelphia, PA)
    …documents are accurately maintained. The Distribution Supervisor is responsible for safety , quality and compliance , delivery, cost performance, key performance ... network. Packaging can be configured to hold a single product or multiple products as determined by study requirements....a Patient First culture through excellence in quality and compliance , and to the safety of every… more
    HireLifeScience (03/26/24)
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  • Aequor (Thousand Oaks, CA)
    …the product 's life cycle. Assesses the effectiveness of the safety periodic reporting processes to determine areas for continuous improvement. Responsible for ... shortlist EOD Friday 3/15 Global Periodic Reports Scientist Organization Global Patient Safety & Pediatrics Group Purpose Group is accountable for production and… more
    HireLifeScience (03/14/24)
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  • Merck & Co. (Rahway, NJ)
    …and Skills: Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to prepare Standard Operating Procedures (SOP) and ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
    HireLifeScience (03/23/24)
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  • Catalent (Philadelphia, PA)
    …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... to identify operating efficiencies to continuously improve and promote safety , quality, compliance , delivery, cost, and engagement.Lead investigations… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. Develops and improves site policies, prepares and submits regulatory ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...as an emergency response coordinator. Monitors and ensures site compliance with local, state, and federal standards for occupational… more
    HireLifeScience (03/23/24)
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  • Catalent (Harman, WV)
    …trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Build effective teams that apply their diverse skills and ... of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and… more
    HireLifeScience (03/27/24)
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  • Catalent (Harman, WV)
    …that aligns with regulatory requirements/expectations.Interface with all other departments to ensure compliance with cGMP.Monitor site compliance to FDA, EU and ... all other applicable requirements.Analyze, resolve, or assist in solving compliance and customer issues.Ensure regulatory and customer audits are managed… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and… more
    HireLifeScience (03/28/24)
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  • Merck & Co. (Rahway, NJ)
    …Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, and ... and disassembly, cleaning, and processing of raw materials into finished drug product . These individuals are expected to partner with and support formulation… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Rahway, NJ)
    …experience to support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead ... plant as needed. The position is responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility… more
    HireLifeScience (03/26/24)
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