Quality Systems Specialist with Veeva, biotech and Microsoft suite || Hybrid to Waltham, MA - DMS Vision Inc

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Quality Systems Specialist

Hybrid role in Waltham, MA ( Local only)
Duration 5 months (with extension possible)


Must Have
vs.
Plus 2-3 years exp. In biotech or regulated industry (required)
2-3 years exp. Microsoft Suite (required)
2-3 years exp. Veeva or ComplianceWire admin (Highly desired)

Job description



KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards)
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 sites
Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/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 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 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 GAMP, andthe ability to determine phase appropriate requirements
Knowledge of Regulatory Compliance and ICH Guidelines

Thank you

Akhilesh@dmsvisions.com

972-645-0322