Job Details
Posted 19 September, 2026
Job Id: 630979
Quality Specialist, CQA
Job Description
Pay range: 40-50/hr
*depending on exp
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 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 3-6 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
* Familiarity with Co-Pilot a plus
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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