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Quality Systems Specialist
4 months ago
Title: Quality Systems Specialist
Status: Contract through end of year
Location: Hybrid in Waltham, MA
Hourly pay rate: $45
Hybrid- 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 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
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