Quality Specialist, CQA

Quality Specialist, CQA
6-month Contract
Hybrid in Waltham, MA
Must be able to work on a W2

Requirements

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

Qualifications

Bachelor’s degree or higher in a relevant computer, technical, quality, or scientific discipline, preferably multidisciplinary with a strong technical and quality background.
Minimum of 3-6 years of experience in commercial pharma, CRO, clinical pharma, or a healthcare facility.
Proficient in MS 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.
Familiarity with Co-Pilot is a plus.