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The Quality Assurance Specialist works closely with all facility personnel to ensure excellent quality performance and full compliance with cGMP and Food Safety requirements. The Quality Assurance Specialist is responsible for the management of quality systems to ensure compliance with quality and regulatory requirements and corporate quality standards.
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Knowledge of cGMP manufacturing and GDP. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: HPLC, DSC, KF Titrator, etc. Use a variety of laboratory instrumentation (KF Titrator, DSC, HPLC, Particle Size, Tensile Tester, spectrophotometer) and computer systems to collect and record data.
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Prefer Operational Excellence experience in a regulated industry such as pharmaceutical, nutraceutical or food processing industries, with familiarity of cGMP and other regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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6-9 years of experience performing operations and maintenance on utility systems, HVAC systems and/or manufacturing equipment in a CGMP Biotech/Pharmaceutical manufacturing environment.
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Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Trend (OOT) and unexpected events. Strong technical skills and experience in commercial biopharmaceutical Quality/Manufacturing in the areas of microbiology, environmental monitoring, microbiological testing, cell culture and/or purification, engineering or validation.
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Must have a complete understanding of company’s policies, SOPs, QPs, EPs, HACCP and cGMP that pertain to their department to ensure quality, safety, efficiency and sustainability. Familiarity with plant equipment and operations (material handling, packaging, process heating & cooling systems, flow control, instrumentation.
$70,000 - $95,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center.
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Evaluate executed audits, including customer audits, to define current quality trends identified as risks/issues and determine impact on global quality systems and initiate actions, as needed.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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3+ years of quality experience in the food industry; knowledge and proven experience with food safety programs and systems: GFSI (BRC or SQF preferred), internal auditing, cGMPs, HACCP, FSMA.
$68,000ExpandApply NowActive JobUpdated 3 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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Quality:Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, Quality) of the products manufactured at Evonik Tippecanoe Laboratories.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Manage Quality Labs (micro and qc) as well as the document control function encompassing all quality systems. Conduct in-house cGMP training and awareness programs for relevant Quality staff and other employees as needed.
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Strong knowledge of aseptic techniques, cGMP regulations, and quality management systems. As the Aseptic Production Manager, you will be responsible for overseeing the aseptic production processes to ensure the highest level of quality and efficiency.
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Familiarity with quality-based computer systems such as LIMS. Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
$23.5 an hourFull-timeExpandApply NowActive JobUpdated 3 months ago
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