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Ensure timely manufacturing of all liquid parenteral cGMP products using aseptic processing technology to deliver high-quality sterile products to the pharmaceutical industry. Lead and/or conduct investigations, document revisions, protocol creation, and CAPA projects.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Quality/Compliance - Adherence to CMTI Quality systems/cGMP •Delivery - ensuring a timely flow and completion of micronization and milling jobs •Cost - Ensure base cost and inventory management, process efficiency and resource utilization.
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Experience in writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable. Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP.
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Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a and a clear understanding of FDA’s QSR and cGMP, and a good grounding in statistics would be instrumental to success.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Additional job responsibilities will include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implement and maintain required cGMP compliant systems.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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This Quality team member will be responsible for initiating and assisting in investigations and troubleshooting while adhering to cGMP and GDP practices. Involvement in continuous improvement initiatives and laboratory investigations.
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Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP is preferred. Participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Quality Operations Specialist in this role is responsible for performing various and complex investigations that ensure compliance with CGMP, implemented standard operating procedures, validated processes and established facility and quality systems.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Manufacturing Engineer for Cytiva is responsible for the design and continuous improvement of safe and efficient manufacturing processes and for investigations into Safety, Quality, Delivery, Inventory, and Productivity, determining Root Cause and driving short term countermeasures and permanent solutions to correct problems.
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The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
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Compliance with all applicable regulatory and accrediting agencies and cGMP expectations, including, but not limited to: Facility and equipment maintenance, validation review and approval, training (internal, continuing education, proficiency testing, annual GMP, etc.
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Provide oversight, direction and counsel to other site functions on validation matters: investigations, CAPA management and process improvements related to validated systems. Essential Duties & Responsibilities: •Ensures the validation policies and procedures are in accordance to cGMP regulations and industry standards.
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This position requires technical expertise in bioreactor operations, cell biology and knowledge of initiating batch records, protocols, investigations and other technical documents. The candidate will be responsible for executing cell culture batches from L to 0 L volumes engineering and clinical batches in a cGMP environment.
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The ideal candidate will have: Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment preferred 1+ years of experience in the Biopharma 1+ years of quality experience 3+ years with MS Office 365 Bachelor’s Degree in Science (Biology, Chemistry, etc) Thank you.
$35.71 - $36.23 an hourExpandApply NowActive JobUpdated Yesterday
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