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Performs all work in adherence to the Companys cGMP and safety standards and procedures. Adhere to Noven policies regarding cGMP Good Documentation Practices. Knowledge of CGMPs and FDA CFRs. AutoCAD and PLC programming/troubleshooting a plus.
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The Process Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner.
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The candidate will be responsible in the purification of L to 0L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
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Ensure OSHA regulations, cGMP principles and BBA SOPS are adhered to. Position Title: Director of Hospital Services and ManufacturingDepartment: ExecutiveReports To: Chief Executive OfficerPosition(s) Supervised: Hospital Services/Components Staff, Equipment Specialist, Mobile Collections StaffPOSITION SUMMARYEnsuring alignment of teams with organizational goals and compliance with regulatory guidelines.
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Work with the department Associate Team Leaders and Team Leaders to ensure compliance with all cGMP, ISO and FDA guidelines for warehouse activities. Experience with the safe and efficient use material handling equipment such as a floor jack, hand truck, order picker, and forklift is required.
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Perform routine laboratory cleaning activities Knowledge, Skills, & Abilities- Experience in pharmaceutical industry or clinical background with cGMP preferred- Microbiology Laboratory experience preferred.
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Knowledge of cGMP requirements for life sciences projects. Strong understanding and knowledge of life sciences markets and processes (fermentation, cell / gene therapy, API, blood products, purification, fill / finish, medical devices, etc.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. And we inspire growth and development in the teams at our donation centers, offices, and labs.
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Pcr,elisa,assay,quality assurance,Quality control,cGMP,Cell Therapy,Flow Cytometry. pcr, elisa, assay, quality assurance, Quality control, cGMP, Cell Therapy, Flow Cytometry. Basic knowledge of CGMP regulations.
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What you bring to Takeda:BS Degree in Science or Engineering with 8 years of relevant experienceProven record of cross-functional technical leadership, including, motivate, and lead technical rigorKnowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies.
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CGTP, cGMP, HCT/P Final Guidance on Minimal Manipulation and Homologous Use, regulatory submissions, regulated product marketing and labeling, clinical trials, and other applicable state, federal, or international regulations.
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Manager, Global External Manufacturing, Sterile Drug Product works to ensure uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
$133,280 - $172,480 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Repair and maintain items necessary to maintain process equipment in cGMP conditionAssist in day-to-day support of operators, adjustments, setups, and change overResponsible to report safety, quality, and regulatory compliance concerns to leadership.
$26.35 - $37.47 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Selection of suitable plasmapheresis donors by performing physical examinations and taking medical histories on all donors through the use of FDA approved Standard Operating Procedure (SOP) Manual, current State and Federal guidelines, OSHA, CLIA, CGMP, all internal company procedures and personal education and experience.
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Perform processing, analytical testing, packaging and labeling of cord blood product, associated cord blood sample(s), PBSC product(s) and PBSC associated sample(s), according to procedures of NMDP, AABB, FACT, FDA, ISO, FDA, organizational and cGMP.
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