Clinical IT Quality Control Analyst
New
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Sarah Cannon Research InstituteClinical Research
This is a remote position based in the USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 3+ years
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor's Degree (professional qualified experience may be substituted).
- 3+ years of professional work experience in clinical research, biotech, or pharmaceutical environments.
- Direct experience in a QA/QC role in computerized systems validation.
- Expertise in FDA GxP requirements for systems and 21 CFR Part 11.
- Understanding of FDA software validation guidelines.
- Knowledge of industry and international standards for software quality (e.g., GAMP V, PIC/S, ICH).
- Experience in GCP clinical space (e.g., CRO or SMO) highly preferred.
- Familiarity with EU regulations such as Annex 11 preferred.
Responsibilities
- Oversee quality control and assurance of software, process, and data integrity validation.
- Provide guidance on corporate and regulatory requirements related to software validation and GxP.
- Review validation life cycle documents including assessments, system plans, risk management plans, and summary reports.
- Support the preparation, execution, and reporting for IQ, OQ, and PQ protocols.
- Perform periodic reviews of system documentation to ensure continued regulatory compliance.
- Conduct quality reviews of changes impacting validated systems and processes.
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