- Insmed Incorporated (Columbus, OH)
- …for authentic and experienced Therapeutic Specialists with demonstrated success in new product launches who are committed to our mission to transform the lives ... RESPECT and ACCOUNTABILITY to the highest standards The Therapeutic Specialist will possess a high clinical aptitude and seasoned...and commitment to winning the right way (culture of compliance ) Foster an entrepreneurial spirit with a focus on… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Specialist , Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and ... Compliance and leads global quality support to all internal...Manufacturing groups and associated functional areas related to the Product Quality Complaint (PQC) system. They also support the… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Eisai is in the midst of an important launch of a new product in the US focused on educating HCPs on a treatment for appropriate individuals suffering ... mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who… more
- Merck & Co. (Durham, NC)
- …issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must ... Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist ...system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor… more
- Merck & Co. (Durham, NC)
- …The facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, lyophilization, product inspection, ... and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities requiring support include the capital project to… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position is ... responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may… more
- Merck & Co. (Rahway, NJ)
- Job Description SSO Operations Specialist Job Description The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility ... and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities while… more
- Merck & Co. (Ames, IA)
- Job Description Responsibilities: The key responsibilities of the Senior Specialist can be divided in the 3 elements:Site Production PlanningIn coordination with ... orders as required based on schedule/inventory changes.Coordinate material flows throughout product /BOM changes, obsolescence, and/or materials due to new product… more
- Aequor (New Brunswick, NJ)
- …degree required Duration: 6 months (possibility of extension)Job Description: Transportation Specialist This role is 100% Onsite, New Brunswick Work Schedule: Mon ... and temperature controlled shipments of clinical materials and drug product . Collect and compile relevant shipment details and prepare...A minimum of 3 years experience as a Transportation Specialist or a similar role in logistics; experience in… more
- Merck & Co. (Rahway, NJ)
- …writing and outcome analysisInternal / External customer engagementRegulatory & compliance knowledgeLifecycle management of CA portfolioIn-depth portfolio product ... Job DescriptionThe Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to...materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, NJ Legend manufacturing site.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based in Raritan, NJ. Role ... cross functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Provides technical expertise in support of an… more
- Merck & Co. (Rahway, NJ)
- …of outages that can impact our operations.The engineer will also work with the Print Product Manager to adopt and set a vision, roadmap, manage the backlog and set ... with our IT and business goals. The engineer will also work with the product manager to establish our incident and support framework.The nature of the position… more
- 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 ... striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (eg clinical, distribution, manufacturing) Practice… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … Specialist II - Engineering/Validation is responsible for cGMP compliance ensuring all FDA regulations, internal procedures/specifications, and other regulatory ... Experience Requirements Must possess strong knowledge of sterile drug product manufacturing.Must be detail-oriented with exceptional planning and organizational… more
- Insmed Incorporated (Denver, CO)
- …for authentic and experienced Therapeutic Specialists with demonstrated success in new product launches who are committed to our mission to transform the lives ... the current rare disease market.Maintain exceptional knowledge of: disease state, product , customer, orphan/rare and specialty drug market, competitive landscape and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …floor. Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Releases product based on ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. We ... will reviews manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... documentation (SOP, batch records, reports) associated with the manufacture of product , requiring minimal direction Ability to investigate and write up Deviation… more
- Cummins Inc. (Columbus, IN)
- **eMobility Product Compliance Specialist ** **Description** This product focused position performs established technical tasks at the product and ... to success in the role. Operates as a recognized specialist in a discipline or product area...Create internal processes and structures to implement and track product compliance of e-mobility products **Job** ENGINEERING… more
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