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Collaborates with other functional work teams e.g., Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials.
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As a Lab Production Technician, you will be responsible for: You will perform complex compounding, manufacturing (cyclotron and chemistry module operation) and quality control processes (utilizing analytical equipment TLC, HPLC, GC), under supervision as required by State and Federal law.
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Author, review, certify, and/or maintain information awareness and security management plans to include RMF Implementation Plans, System Security Management Plans, Information Support Plans, Program Protection Plans (PPPs), Security Risk Analyses, Security Vulnerability and Countermeasure Analyses, Security Concepts of Operations, Operational Security (OPSEC) Plans, and other system/network security related documents.
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Sets up and operates plastic extrusion equipment to manufacture miniature, precision tubing to established quality standards in order to meet production demands. Knows process of screw and tool design, resin characteristics, temperature control, automated feedback loops, and ancillary downstream equipment such as burst testers and slickers.
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All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control, Process Development and Health, Safety & Environment.
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You will provide immediate in-field oversight to crews on safety, quality control, and correct installation methods to ensure an efficient installation. Work with Operations Manager to fulfill any necessary system upgrades/repairs to support our solar equipment.
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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.
$160,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Your cross-functional partners will include Design Engineering, Product Management, Operations, Quality, and Service, among others. Be responsible for risk mitigation and change management control for the program(s) you lead.
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Job Title: Information System Security Manager (ISSM) Job Location: Lexington, MA Overview: Abacus Technology is seeking an Information System Security Manager (ISSM) to act as a technical advisor for security issues for the Command, Control, Communication, Intelligence and Networks (C3I&N) Directorate at Hanscom AFB. This is a full-time position.
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Evaluate and revising operational policies and guidelines for the organization Implementation of MSA KPI’s, including but not limited to labor allocation, client census and engagement, and staff retention Quality Control and Data Analysis Meet weekly and when necessary, with the VP of Operations to review and strategize daily activities as well as expansion development Work with the Finance Department to implement MSA financial plans.
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You will also use Microsoft Excel to maintain records of stock, needed release dates, and position to program need on WIP. Additionally, you will work with Manufacturing Supervisor, Manufacturing Engineer, Quality Engineer, Program Manager, etc.
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Quality assurance, Compliance, GMP, Document control, Batch Record, Batch Record Review, product release, investigations, Root cause analysis, iso 13485, audit, quality compliance.
$20 - $28 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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As part of ceramics process operations, the Quality Control Technician is responsible for inspecting ceramic parts at 0x, 4x and 7x magnification for visual defects, feature defects and working with engineering team to improve our process.
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Support the system/application Authorization and Accreditation (A&A) effort to include assessing and guiding the quality and completeness of A&A activities, tasks and resulting artifacts mandated by governing DoD and Air Force policies (i.e., Risk Management Framework (RMF.
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20-30%: Support QC operations, including data review, data trending, maintenance of equipment and reagents, lab housekeeping, and compliance with quality systems (e.g., SOP revisions). External contacts may include departments like Analytical Development, R&D, Quality Assurance, Regulatory, Manufacturing, and Facilities and Engineering.
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quality control operations jobs in Billerica, MA
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