Dexian DISYS
Quality Systems Specialist
Dexian DISYS, Waltham, Massachusetts, United States, 02254
Quality Systems Specialist
Job Title: Quality Systems SpecialistLocation: Waltham, MassachusettsDuration: 4+ monthsDescription:
This is a Hybrid role with onsite days Tuesday - Thursday.Responsibilities: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.Assist in 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 system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems.Support investigation, escalation, and resolution of issues identified on the system.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.Support manager with ongoing communication from vendor/IT where required.Provide customer support through system and training management and onboarding of new users.Generate metrics to support quality systems.Support regular system updates/releases and provide assessment of and recommendations regarding new features.Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created, and/or modified.ACADEMIC/TECHNICAL QUALIFICATIONS:Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multidisciplinary 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 Compliance Wire is a plus.Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements.*Knowledge of Regulatory Compliance and ICH Guidelines.
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Job Title: Quality Systems SpecialistLocation: Waltham, MassachusettsDuration: 4+ monthsDescription:
This is a Hybrid role with onsite days Tuesday - Thursday.Responsibilities: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.Assist in 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 system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems.Support investigation, escalation, and resolution of issues identified on the system.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.Support manager with ongoing communication from vendor/IT where required.Provide customer support through system and training management and onboarding of new users.Generate metrics to support quality systems.Support regular system updates/releases and provide assessment of and recommendations regarding new features.Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created, and/or modified.ACADEMIC/TECHNICAL QUALIFICATIONS:Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multidisciplinary 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 Compliance Wire is a plus.Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements.*Knowledge of Regulatory Compliance and ICH Guidelines.
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