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May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment. As the site Quality Assurance Manager , you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 20 days ago - 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.
$82,800 - $136,600 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Ability to make Quality decisions related to Sterility Assurance for manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
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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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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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Experience with Veeva (Quality Docs, QMS and Training modules) a plus. Knowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommended. This includes documentation control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems.
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Develop and monitor quality system processes, including CAPA, change control, design control, complaint investigations, supplier oversight, internal audit, nonconforming materials.
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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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The Supervisor must collaborate with cross-functional partners, such as Supply Chain, Manufacturing Sciences, Manufacturing Technical Support, Quality Assurance, Quality Control, Validation and Facilities to accomplish organizational objectives (e.g., meeting commercial demand, new process transfers, new manufacturing area commissioning and validation.
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Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times. Title: Quality Laboratory Technician. Experience using LIMS required; CELabs LIMS Systems preferred.
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Experience working in a Quality Control Laboratory or with enterprise computer systems, and GMP Quality Systems such as TrackWise, LIMS, LES, Empower, and MODA. Manages all aspects of QMS processes, including Change Control, Deviations, CAPAs, and Tasks.
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Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPA. Expertise in root cause analysis. Solid understanding of quality risk management (QRM) principles and statistical concepts.
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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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Understand converting facilities’ quality requirements including SQF, CGMP, and other quality programs. The Quality Control & Proofing Technician is responsible for the quality check of all prepress graphics files prior to being sent to customers for final approval.
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cgmp quality control jobs in Brooklyn, NY
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