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In close collaboration with Materials Management, Quality Control and Quality Assurance. Job Title: Cell Therapy Specialist / Bio-Manufacturing Technician (GMP/cGMP background.
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Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.) In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
$82,800 - $136,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. A bachelor's or master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least 3 years of related work experience.
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Our R&D Quality Control team seeks a talented Senior QC Analytical Chemist to join an innovative organization to serve as Cresilon's Subject Matter Expert (SME) and technical leader in cGMP Analytical Chemistry.
$110,000 - $135,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
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AA Degree with 1+ years of cGMP experience. Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations.
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AA Degree with 1+ years of cGMP experience High School Degree and 2+ years of cGMP experience. Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
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BA / BS Degree in Sciences Field OR AA Degree with 1+ years of cGMP experience OR High School Degree and 2+ years of cGMP experience. Do you have a background in cGMP manufacturing.
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AA Degree with 1+ years of cGMP experienceOR. High School Degree and 2+ years of cGMP experience. We are seeking a highly motivated, Cell Therapy Specialist to join our newly formed Cell Therapy Manufacturing team at our brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
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Supervising Change Controls, Document Control Quality Metrics, and supplier quality. Our client's Quality Assurance group is actively searching for a driven individual to join their expanding team as a QA Supervisor within the QA Compliance Group.
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Quality Assurance : Oversee the Quality Assurance function, including batch release, product disposition, deviation management, change control, and CAPA. Quality Systems : Develop, implement, and maintain robust quality systems and processes to ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
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Accountable for the effective execution of processes carried out under departmental leaders (Pest Control, GMP Work Orders, Batch Disposition and Operational Quality Walk Through) Minimum of ten (10) years in Quality (QA, QC, QS and/or Compliance) with progressive experience in a regulated cGMP industry is required, with three (3) years’ management experience.
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The position will be reporting to the Director, Quality Control & Assurance. The position is intended for a motivated professional with an understanding of cosmetics cGMP, auditing, root cause analysis, and risk mitigation who can shine with little supervision.
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2+ years of relevant experience in biotechnology or pharmaceutical industry with emphasis on quality control testing preferred. Perform routine quality control (QC) activities required for final product release and stability monitoring.
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The Quality Control Technical Services (QCTS) Sr. Analyst will be responsible for working under guidance of QCTS Manager responsible for optimization, qualification, validation, transfer, compendial verification, stability, and QC implementation of methods associated with cGMP production of cell therapy products.
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cgmp quality control jobs in Brooklyn, NY
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