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REQUIRES: Master’s or equivalent in Computer Science/Applications, Information Technology, Business Management/Administration or Electronics Engineering + 1 year experience as Software Quality Engineer, Software Quality Assurance Analyst, Test Engineer, Quality/Product Test Professional or related.
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Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy commercial manufacturing facility. + Leads the local process owners for Quality Systems (deviation, capa, change control, data integrity, training, risk management, and audits.
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This is Hybrid opportunity in NYC. Looking for: SME in Quality Management Initiatives Must have HEDIS (3 years experience) SQL background Management skills - will manage a team of 4 Hybrid role - 3 days in the office.
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Build, deploy and reinforce learning tools and materials to support quality event management capability development. In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes.
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Ensures required quality procedures are established including CAPA, Non-Conforming Product, Risk Management, Post-market-surveillance, Purchasing Controls, Management Review, Traceability, Employee Controls, Post market management, Change Control, Advisory Notifications, Supplier compliance and others as coordinated within the Quality team and with other cross-functional departments.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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This role involves managing all aspects of the Quality Management System, from the receipt of raw materials and finished goods to the manufacturing, handling, storage, and distribution of dietary supplements, in accordance with established GMP requirements.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Responsibilities The Quality Assurance Specialist for Small molecule is responsible for management of deviations and customer complaints including coordination, review / approval of deviations and complaint investigations.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The position is responsible for implementation and management of ADCT’s system to manage quality throughout all stages of clinical trials and will report to the Vice President of Clinical Operations within the Chief Medical Officer (CMO) organization.
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The Senior Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell Therapy Quality Risk Management Program in accordance with BMS policies, standards, procedures and global cGMPs∯*∯ The primary focus for this role is to facilitate the risk assessments, in order to identify risk areas and support implementing risk mitigation measures for S-12 operations, cGMP compliance and business continuity.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Quality Assurance Specialist for Small molecule is responsible for management of deviations and customer complaints including coordination, review / approval of deviations and complaint investigations.
Full-timeRemoteExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The position is responsible for implementation and management of system to manage quality throughout all stages of clinical trials and will report to the Vice President of Clinical Operations within the Chief Medical Officer (CMO) organization.
$230,000 a yearExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Support and track deviations, investigations, and CAPA plans for the GMP Facilities Department Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross-functionally with Facility Management, QA, Validation, and Business Area Management.
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The Regulatory & Quality Assurance Professional position is an office position with primarily administrative duties related to warehousing, shipping, and logistics. Maintain databases to support Raw Materials Data Management.
$70,000 a yearFull-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Quality management activities as assigned. Must have knowledge and experience with GMP, Quality, and compliance. complaints, deviations, investigations and CAPA management.
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Author documents and standard operating procedures, review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Strong technical writing and oral communication abilities · Experience working with electronic quality management and laboratory information management systems.
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quality management jobs Title: quality in Rahway, NJ
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