Quality Systems Specialist

Associate MSP Recruiter at GForce Life Sciences

Quality Systems Specialist

6‑month Contract

Hybrid, Waltham, MA

Must be able to work on a W2

• Support global Quality Systems and related operations to ensure compliance and fitness for intended use in accordance with applicable global SOPs, under the direction of the QS&C management team
• Assist in governance of Quality System applications, including harmonization of processes across sites
• Participate in gathering requirements for system improvements and ongoing maintenance through meetings and workshops with Site Process Owners and business subject matter experts
• Participate in user forums to gather ongoing requirements and support prioritization and issue triage
• Follow up on requests, issues, and projects and report status to managers and working teams
• Initiate and manage change controls, including required documentation, through completion
• Support maintenance of systems in a validated state, including periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems
• Support investigation, escalation, and resolution of system‑related issues
• Support validation activities as requested, including requirements gathering, validation planning, design qualification, authoring and execution of test plans and test scripts, discrepancy management, and authoring system descriptions and validation summary reports
• Support ongoing communication from vendors and IT, as required
• Provide customer support through system support, training management, and onboarding of new users
• Generate metrics to support Quality Systems
• Support regular system updates and releases, including assessment of and recommendations regarding new features
• Maintain key user‑related documentation and ensure documentation remains current as functionalities are enabled, created, or modified

• Bachelor’s degree or higher in a relevant computer, technical, quality, or scientific discipline
• Minimum of 3–6 years of experience in a high‑volume commercial or clinical pharmaceutical or healthcare environment
• Proficiency in MS Word, Excel, and Quality System processes
• Experience with Veeva Vault Quality Docs, Track Wise, and Compliance Wire preferred
• Understanding and working knowledge of U.S. FDA and European regulatory requirements and GAMP, with the ability to determine phase‑appropriate requirements
• Knowledge of regulatory compliance and ICH guidelines

Associate

Contract

Quality Assurance and Other

Pharmaceutical Manufacturing and Hospitals and Health Care