Quality Specialist, CQA

Clinical Quality Specialist
6-month Contract
Hybrid in Waltham, MA

Requirements

Support Clinical Quality operations to ensure compliance of clinical studies, vendor management, and inspection readiness in accordance with approved procedures, global regulations, ICH guidelines, and GxP requirements.
Support the processing of audit reports, change controls, deviations, and audit plans.
Support the Clinical Quality team in the coordination, investigation, escalation, and resolution of issues identified during Clinical Quality operations.
Support the scheduling of audits with internal and external stakeholders.
Collect and generate metrics for Clinical Quality operations.
Assist in gathering requirements for process improvements and ongoing maintenance by participating in meetings and workshops with Site Process Owners and business SMEs.
Participate in Clinical Quality meetings and additional forums, including Inspection Readiness and Regulatory Inspections.
Support internal and external stakeholders in the processing of deviations, quality investigations, and audits.
Follow up on requests, issues, and projects, and report status updates to management and the Clinical Quality team.
Support the management and maintenance of the Clinical Quality Vendor Management database.
Provide Clinical Quality support through training management and onboarding of new employees.

Qualifications

Bachelor’s degree or higher in a relevant computer, technical, quality, or scientific discipline; multidisciplinary background with strong technical and quality experience preferred.
2–5 years of experience in commercial pharmaceutical, CRO, clinical pharmaceutical, or healthcare environments.
Proficiency with Microsoft Word, Excel, and Quality System processes.
Experience with Veeva, TrackWise, and ComplianceWire is a plus.
Understanding and working knowledge of U.S. FDA and European regulatory requirements.
Knowledge of regulatory compliance, ICH guidelines, and GxP standards.