Quality System Specialist

2 weeks ago


Waltham, United States GForce Life Sciences Full time

Internal Title: Quality Systems Specialist Duration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs)

Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes across sites Assist in gathering requirements for improvements and ongoing maintenance by participating in meetings/workshops with Site Process Owners and business SMEs Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues Follow-up on requests, issues, and projects and report statuses to manager/ working teams Initiate and manage change controls, with associated documentation requirements, to completion Ensure the system is maintained in a validated state by participating in periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems Support validation activities as requested; this includes but is not limited to requirements gathering, validation planning, design qualification, authoring test plans, and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports Qualifications: Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background Minimum of 3-6 years of experience in a high-volume commercial/clinical pharma/healthcare facility Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus. Understanding and working knowledge of US FDA and European regulatory requirements and GMP, and the ability to determine phase-appropriate requirements Knowledge of Regulatory Compliance and ICH Guidelines

#J-18808-Ljbffr



  • Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...


  • Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...


  • Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...


  • Waltham, United States GForce Life Sciences Full time

    Internal Title: Quality Systems SpecialistDuration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs)Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes across sitesAssist in gathering requirements for improvements and ongoing maintenance by participating in...


  • Waltham, United States GForce Life Sciences Full time

    Internal Title: Quality Systems SpecialistDuration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs)Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes across sitesAssist in gathering requirements for improvements and ongoing maintenance by participating in...


  • Waltham, United States Precision Life Sciences Full time

    JOB DESCRIPTION: Quality System Specialist ·The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. Position details: ·Assist in governance of Quality System...


  • Waltham, United States Alkermes, Inc. Full time

    Quality Systems Specialist II KEY AREAS OF JOB ACCOUNTABILITY: The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, as assigned, to ensure that they are compliant and fit for intended use in accordance with applicable...


  • Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Quality Systems Specialist IIKEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, as assigned, to ensure that they are compliant and fit for intended use in accordance with applicable...


  • Waltham, United States Talent Groups Full time

    **Responsibilities**: - Support global Quality Systems operations for compliance and efficiency. - Assist in system governance and harmonization across sites. - Gather requirements for system improvements and maintenance. - Manage change controls and ensure system validation. - Support issue resolution and validation activities. - Provide user support and...


  • Waltham, United States BostonGene Full time

    Position Summary BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations. Responsibilities ? Ensure all activities are conducted in compliance with...


  • Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.Responsibilities● Ensure all activities are conducted in compliance with...


  • Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.Responsibilities● Ensure all activities are conducted in compliance with...


  • Waltham, United States Editas Medicine Full time

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the...


  • Waltham, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...


  • Waltham, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...


  • Waltham, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...


  • Waltham, United States Editas Medicine Full time

    Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....


  • Waltham, United States GForce Life Sciences Full time

    Responsibilities • Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.• Perform system-based risk assessments in determining GxP applicability of...

  • Training Specialist

    16 hours ago


    Waltham, United States AbbVie Full time

    **Company Description** Purpose The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and...


  • Waltham, United States Springwell Inc Full time

    Springwell is seeking compassionate community specialists to provide information to older adults, family caregivers, individuals with disabilities, and community professionals. DESCRIPTION: Information and Referral Specialists work with consumers over the phone, via email, and in person at the Springwell office. They provide support and consultation to...