Manufacturing Operations Specialist Katalyst Healthcares & Life SciencesManufacturing Operations SpecialistDurham, NCRoles & Responsibilities: Operate manufacturing equipment following SOPs and batch records. Associate or bachelor's degree in biology, Biotechnology, Chemistry, or related field.
Manufacturing Operations Specialist Karwell TechnologiesManufacturing Operations SpecialistDurham, NCRoles & Responsibilities: Operate manufacturing equipment following SOPs and batch records. Associate or bachelor's degree in biology, Biotechnology, Chemistry, or related field.
Manufacturing QA Specialist Guerbet SAManufacturing QA SpecialistRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Manufacturing QA Specialist - 2nd shift Guerbet SAManufacturing QA Specialist - 2nd shiftRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Manufacturing Quality Assurance Specialist NovartisManufacturing Quality Assurance SpecialistDurham, North CarolinaCollaboration, Communication Skills (Inactive), Data Integrity, Digital saviness (Inactive), Leadership, Managing Ambiguity, Operational Excellence, Problem Solving Skills (Inactive), Regulatory Requirements knowledge (Inactive) If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information.
NewAssociate Manufacturing Process Specialist 6014-Janssen Biotech Legal EntityAssociate Manufacturing Process SpecialistWilson, North CarolinaDemonstrates expertise in a number of the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities. Provides technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations.
Senior SAP EWM Functional Specialist – Manufacturing Integration Alcami CorporationSenior SAP EWM Functional Specialist – Manufacturing IntegrationDurham, North CarolinaFull timeConfigure, support, and optimize SAP EWM processes including inbound/outbound, staging, goods issue/receipt, batch handling, replenishment, physical inventory, warehouse structure, storage types, warehouse process types, putaway and stock-removal strategies, warehouse tasks/orders, and production supply processes. Job Summary: The Senior SAP EWM Functional Specialist – Manufacturing Integration is accountable for driving operational excellence through hands-on support, configuration, and optimization of SAP S/4HANA, with primary responsibility for Extended Warehouse Management (EWM) and its integration with manufacturing, including PP/PP-PI processes.
Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness AmgenSpecialist Manufacturing New Product Introduction (NPI):Downstream ReadinessHolly Springs, North CarolinaIn addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsibilities: New Product Introduction(NPI)leadcoordinatingwithManufacturing, Process Development,Supply Chain, Planning, Facilities and Engineering, Quality, and other teamsto introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools.
Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness AmgenSpecialist Manufacturing New Product Introduction (NPI): Upstream ReadinessHolly Springs, North CarolinaIn addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsibilities: New Product Introduction(NPI)leadcoordinatingwithManufacturing, Process Development,Supply Chain, Planning, Facilities and Engineering, Quality, and other teamsto introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools.
Manufacturing Service & Repair Specialist Sika CorpManufacturing Service & Repair SpecialistRaleigh, NCRemoteWith more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries. Sika is a specialty chemicals company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry.
NewAssociate Manufacturing Process Specialist Johnson & JohnsonAssociate Manufacturing Process SpecialistWilson, NCDemonstrates expertise in a number of the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities. Provides technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations.
Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3 Alcami CorporationSr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3Morrisville, North CarolinaFull timeAt Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.
Specialist Manufacturing Investigations AmgenSpecialist Manufacturing InvestigationsHolly Springs, North CarolinaWhen completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Specialist - Manufacturing Investigations Amgen IncSpecialist - Manufacturing InvestigationsHolly Springs, NCIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis, Design of Experiment etc.) critical thinking, project management, and quality systems.
Senior QA Specialist, External Manufacturing, US Bavarian NordicSenior QA Specialist, External Manufacturing, USDurham, North CarolinaRemote$120,000–$155,000 / yearAs a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola . The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.
Senior QA Specialist, External Manufacturing, US Bavarian Nordic ASSenior QA Specialist, External Manufacturing, USDurham, NCRemote$120,000–$155,000 / yearAs a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.
Specialist Manufacturing – Process Owner - Upstream / Downstream / Services AmgenSpecialist Manufacturing – Process Owner - Upstream / Downstream / ServicesHolly Springs, North CarolinaTheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. This roleis responsible forsupporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.
Manufacturing Intelligence Specialist StaffWorthyManufacturing Intelligence SpecialistWilmington, North CarolinaProvide project related engineering services including but not limited to MES development, web development, process historian configuration, network configuration, SQL configuration and general IT support. Perform duties as a technical lead which includes working with and providing guidance for younger, less experienced engineers as needed to satisfy project requirements.
Specialist Manufacturing - Process Owner - Upstream / Downstream / Services Amgen IncSpecialist Manufacturing - Process Owner - Upstream / Downstream / ServicesHolly Springs, NCThe FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. This role is responsible for supporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.
Manufacturing Programs Senior Manager: New Product Introduction (NPI) AmgenManufacturing Programs Senior Manager: New Product Introduction (NPI)Holly Springs, North CarolinaIn addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Responsibilities: New Product Introduction (NPI) subject matter expert coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.