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Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy.
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Knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Delivery of Current State Contamination Control Findings Report Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying and assigning risk (RPN) of identified GAPs to define prioritization in overall CAPA Plan. Delivery of Corrective and Preventive Action Plan based upon risk to remediate GAPs identified in Assessment.
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This includes Master Batch Record changes and approvals, production batch record reviews and disposition activities and initiation and resolution of Quality Systems related to manufacturing (CAPA, Change Control, Deviations.
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This position is responsible for the oversight and management of the deliverables of the Quality Assurance, Document Control, and Quality Supplier Management departments which includes disposition of in-process materials and finished product, labeling and documentation, deviations, CAPAs and product complaints.
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Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
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Quality Control Analyst II , working in. products in accordance with SOPs and cGMP regulations. Contribute to general operations and testing of the QC Molecular Biology laboratory.
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The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
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The Device Quality Expert will be accountable for the Software Quality Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as compliance with relevant domestic and international regulations, standards and guide-lines and customer requirements.
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Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation. cGMP Compliance Specialist 2nd shift needed for a contract opportunity with Yoh Scientific's client located in Cambridge, MA.
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Quality Control and/or Analytical Development experience in Biotech, cGMP areas. We are looking for a Quality Control (QC) professional to join our team as a Senior Quality Control Analyst, supporting our internal GMP cell therapy manufacturing.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred. The Quality Assurance Specialist is an intermediate level professional position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition.
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BS in a relevant scientific discipline or 2-5 years Quality Control experience in a cGMP organization with a focus in Microbiology. skills: Quality control, CAPA, Microbiology, GMP (Good Manufacturing Practice.
$45 - $47.69 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The QC Microbiology associate is responsible for the performance of the cGMP routine/non-routine QC sampling and testing within the function of the QC Microbiology Laboratory supporting our Vaccine manufacturing site.
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Signification experience (7+ years) supporting site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
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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 14 days ago
cgmp quality control jobs in Cambridge, MA
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