Quality Systems Specialist
📋 Role Overview & Responsibilities
Hybrid Details: onsite days: Tuesday, Wednesday and Thursday.
Duration: 7 months to start
Job Description
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 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 applications, including harmonization of processes across sitesAssist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEsParticipate in additional user forums for gathering ongoing requirements and prioritization and triage issuesFollow-up on requests, issues, and projects and report statuses to manager/ working teamsInitiate and manage change controls, with associated documentation requirements, to completionEnsure 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 SystemsSupport investigation, escalation, and resolution of issues identified on the systemSupport validation activities as requested; this includes but is not limited 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 reportsSupport manager with ongoing communication from vendor/IT where requiredProvide customer support through system and training management and onboarding of new usersGenerate metrics to support quality systemsSupport regular system updates/ releases and provide assessment of and recommendations regarding new featuresMaintain 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 multi-disciplinary with a strong technical and quality backgroundMinimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facilityProficient 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 GAMP, and the ability to determine phase appropriate requirementsKnowledge of Regulatory Compliance and ICH Guidelines
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This position is located in Waltham, MA with potential relocation and sponsorship assistance depending on candidate qualifications.
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