What are the responsibilities and job description for the Quality Specialist, CQA position at GForce Life Sciences?
6-month Contract
Hybrid in Waltham, MA
Must be able to work on a W2
Requirements
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.
- 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.