• Quality Technician

    Teleflex (Mansfield, MA)
    …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
    Teleflex (04/03/25)
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  • Sr. Software Quality Engineer

    Fresenius Medical Center (Lawrence, MA)
    …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... individuals with disabilities to perform the essential functions. . Extended computer -based work in an office environment. **EDUCATION** . Bachelor's Degree required… more
    Fresenius Medical Center (04/24/25)
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  • Manager, Quality Control

    Curia (Hopkinton, MA)
    …to effectively utilize team resources + Expert in cGMP, USP, EP and FDA regulations + Technical competence including the understanding of theory and interpretation ... of all lab techniques + Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software + Strong organizational… more
    Curia (04/26/25)
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  • Manager, Quality Assurance

    Astellas Pharma (Westborough, MA)
    …compliance gaps and implementing corrective actions. Represent the QA function during FDA , EMA, and third-party inspections, and serve as a QA subject matter ... change control systems. + Cross-functional Collaboration: Partner with Manufacturing, QC, Validation , Regulatory Affairs, and Supply Chain to align on QA… more
    Astellas Pharma (04/19/25)
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  • Head of Site Regulatory -Regulatory Site Office

    Sanofi Group (Framingham, MA)
    …a pharmaceutical or biotech organization. + Significant knowledge and experience with FDA /EMA/TGA/HC regulations + Proficient in computer software programs and ... + In-depth understanding of pharmaceutical regulations, guidelines, and standards (eg, FDA , EMA, ICH). + Ability to analyze complex compliance issues, identify… more
    Sanofi Group (04/04/25)
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  • Head of Quality Compliance

    Sanofi Group (Framingham, MA)
    …pharmaceutical or biotech organization. + Significant knowledge and experience with FDA /EMA/TGA/HC regulations + Leading and managing the compliance team, including ... coaching, professional development and performance evaluation.​ + Proficient in computer software programs and applications. + Effective communication skills… more
    Sanofi Group (04/04/25)
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  • Manufacturing Associate, Cell Therapy in

    Bristol Myers Squibb (Devens, MA)
    …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... in close proximity to strong magnets. + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic… more
    Bristol Myers Squibb (05/02/25)
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  • Biologics Development IT Business Partner

    Bristol Myers Squibb (Devens, MA)
    …framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Strong Project Management skills, and ... & Experience** : + Bachelor's or Master's degree in computer science, Bioinformatics, Computational chemistry/Biology, or experience in related field… more
    Bristol Myers Squibb (04/25/25)
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  • Performance Monitoring Manager

    Cardinal Health (Boston, MA)
    …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
    Cardinal Health (04/22/25)
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  • Senior Director, Clinical Trial Configuration

    Takeda Pharmaceuticals (Boston, MA)
    …Capture (EDC), RBQM. + Knowledge of regulations and best practices related to computer system validation , electronic records and signatures and data privacy. + ... analysis plans, CRFs, study reports) and processes. + Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. +… more
    Takeda Pharmaceuticals (05/03/25)
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