- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Pfizer (Andover, MA)
- …and maintaining systems per site needs. + Planning and performing of Computer Systems Validation (CSV) in the regulated environment in collaboration ... and Pfizer's directives and procedures. + Develop/enhance and implement Computer Systems Validation documentation such...Part 11 and Annex 11. + Strong knowledge of computer system validation methodologies. +… more
- Tecomet (Woburn, MA)
- …Tecomet's Environment Management System ; Worldwide Quality Management Systems Software implementation/ validation and harmonization (ETQ); New Product ... systems /programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining...policies and procedures to ensure is in compliance with FDA 21 CFR, Part 820, Quality System … more
- AbbVie (Worcester, MA)
- …Operations, Quality, IT and Maintenance. + Manage and supports control system including standalone Manufacturing equipment, systems upgrades, data migrations ... Data Historian systems . + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP,...PI, Rockwell PLC are required. + Direct experience with system development and validation , including development of… more
- Catalent Pharma Solutions (Chelsea, MA)
- …(GMP) standards + Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating ... new and existing control equipment + Trains users on control system functionality (Programmable Logic Controller, Computer /Control Networks, Control Computers… more
- Integra LifeSciences (Braintree, MA)
- …**RESPONSIBILITIES** + Responsible for supporting the maintenance of the document control system during 1st shift. + Day-to-day management of resources, planning to ... and deadlines + This role ensures compliance within the document management system , document storage, retention, and document reconciliation + Serve as a document… more
- Integra LifeSciences (Boston, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Integra LifeSciences (Braintree, MA)
- …procedures. + Support the implementation of new or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and ... archived materials and solutions. + Assist as needed in test method validation , implementation, and execution. + Provides database support, generate reports and… more
- Cardinal Health (Mansfield, MA)
- …research and analyses to develop design options for components, products, systems and processes. Research and Development Engineering is responsible for developing ... (DHF) Documentation and adherence to guidelines and requirements associated with FDA /QSR design controls. + Participate in multi-departmental teams to manage product… more