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Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc. and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.
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Oversight and continuous improvement and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. Provide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendors/suppliers.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Oversite and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. Provide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Who will be providing 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.
$100,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by adhering to SOFIE’s quality management system and maintaining a state of cGMP control at the site.
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Chemist I - This position will perform in a cGMP environment following FDA and ICH guidelines. Duties include but are not limited to method development, method and instrument validation, raw material, components, drug substance, finished product, and stability testing in accordance with cGMP regulations, regulatory filings and approved procedures.
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Seeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. General knowledge of industry standards and guidelines for quality control laboratory operation.
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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.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Records and maintains all related data and records in adherence to cGMP and quality procedures. Quality Control and Quality Assurance. Quality Assurance - Clinical I , working in.
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Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This is a Senior QA role focused on product compliance and complaints for packaging, labeling, or product (OOS / OOT, deviations, investigations, APQR / APR (Annual Product Quality Review) Annual report writing.
$110,000 - $119,500 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Manager reports directly to the Director of Quality, Bioscience Production and directly manages the Quality team, quality assurance and quality control at the Phillipsburg, NJ and Bridgewater, NJ facilities.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Production Operator will be a highly skilled production operator which will include ensuring that we meet the demand for products, production quality levels and production yield goals while maintaining cost control.
Full-timeExpandApply NowActive JobUpdated 2 days ago
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