• Senior Scientist

    Actalent (Waltham, MA)
    …serve as aSubject Matter Expert (SME) in analytical method transfer and validation , supporting the development and quality control of lipid nanoparticles (LNPs). You ... available. Key Responsibilities: + Act as SME for analytical method transfer and validation . + Support method and process validation activities. + Contribute to… more
    Actalent (07/22/25)
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  • Manager, Automation Engineering- Onsite

    AbbVie (Worcester, MA)
    …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
    AbbVie (06/17/25)
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  • Research Scientist 1 - Immunochemistry

    Charles River Laboratories (Shrewsbury, MA)
    …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
    Charles River Laboratories (06/03/25)
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  • Sr. QA Specialist, Operations

    Catalent Pharma Solutions (Chelsea, MA)
    …including monitoring use of complex equipment; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA ... and update quality documentation and records; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA … more
    Catalent Pharma Solutions (07/24/25)
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  • Quality Control Technician II, Analytical

    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
    Integra LifeSciences (07/22/25)
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  • Sr. Manager Quality Control

    ThermoFisher Scientific (Plainville, MA)
    …You'll ensure the successful execution of in-process and release testing, method validation , and compliance with global regulatory standards - while shaping the ... site's QC lead for client audits and regulatory inspections ( FDA , EMA, Health Canada). + **Enable innovation** : Support...and developing impactful teams. + Background in analytical method validation and technology transfer in a GMP environment. +… more
    ThermoFisher Scientific (07/18/25)
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  • Quality Control Technician II, Analytical

    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
    Integra LifeSciences (07/16/25)
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  • Senior Clinical Outcomes Assessment (COA) Lead

    Sanofi Group (Cambridge, MA)
    …assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers ... asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead...COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation… more
    Sanofi Group (07/15/25)
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  • Principal Supplier Quality Auditor

    Hologic (Marlborough, MA)
    …and/or pharmaceutical regulations, including risk management processes (eg, pFMEAs) and validation protocols (IQ, OQ, PQ). + Familiarity with supplier action plans ... of PPAP (Production Part Approval Process) and global regulatory frameworks ( FDA , Canada, Brazil, Japan, etc.). **Skills** + Strong communication abilities across… more
    Hologic (06/18/25)
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  • Principal Manufacturing Engineer

    Medtronic (Danvers, MA)
    …and other functions that affect product performance. Work to develop various validation protocols, test methods and test fixtures. Navigate various risk activities ... ISO quality system - ISO 9001, ISO 14971, ISO13485, FDA QSR (Quality Systems Regulation) Part 820 and relevant...years of experience with each of the following: Developing validation protocols, test methods and test fixtures; PFMEA &… more
    Medtronic (06/09/25)
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