Clinical Quality Specialist
Talent Groups ·www.talentgroups.com
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Hybrid Details: 3-5 days/week onsite
Duration: 6 months to start
Job Description:
The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of client clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.
Position Details:
Academic/Technical Qualifications:
#LI-Hybrid
Duration: 6 months to start
Job Description:
The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of client clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.
Position Details:
- Support the processing of audit reports, change controls, deviation, and audit plans
- Support CQA team 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 meeting/workshops with Site Process Owners and business SMEs
- Participate in CQA meetings and the additional forums including but not limited to 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 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.
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 2-5 years of experience in commercial pharma, CRO, clinical pharma, or 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 US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards
#LI-Hybrid
Frequently asked questions
Who is hiring for the Clinical Quality Specialist role?
Talent Groups is hiring for the Clinical Quality Specialist position, a Shazamme client. Apply directly on the employer's career site.
Where is the Clinical Quality Specialist job located?
The Clinical Quality Specialist role with Talent Groups is based in Waltham, MA, US. The role is hybrid-friendly.
Is the Clinical Quality Specialist role remote?
Yes — the Clinical Quality Specialist position at Talent Groups is hybrid. Candidates based in US are preferred.
What does the Clinical Quality Specialist role pay?
Talent Groups lists the Clinical Quality Specialist role at USD 40–50 per hour.
Is the Clinical Quality Specialist role full-time or contract?
This is a full time position at Talent Groups.
What experience level is the Clinical Quality Specialist role?
The Clinical Quality Specialist position is aimed at mid-level candidates.
How do I apply for the Clinical Quality Specialist role at Talent Groups?
Apply directly on Talent Groups's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.