Clinical IT Quality Control Analyst
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Job Description
Clinical IT Quality Control Analyst validating software, processes, and data for Sarah Cannon Research Institute’s oncology clinical research programs. Ensuring GxP, 21 CFR Part 11, and FDA validation compliance.
Responsibilities:
- Oversee quality control and assurance of software, process, and data integrity validation processes
- Provide guidance and support to operational teams to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements
- Work with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts
- Support research operations and IT in interpreting corporate and regulatory requirements related to software validation, quality management, and GxP
- Oversee quality activities related to software, process, and data integrity validation
- Review validation lifecycle documents, including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports
- Provide quality guidance through preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
- Assist with periodic review of system documentation
- Provide quality review of changes impacting validated systems and/or processes
- Perform other duties as assigned
Requirements:
- Bachelor's Degree required; professional qualified experience may be substituted for education
- Direct experience in a QA/QC role in computerized systems validation
- Experience in GCP clinical space, such as CRO or SMO, highly preferred
- 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused on FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines
- Experience and knowledge of EU regulations, e.g., Annex 11, preferred
- Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH
- Knowledge of pharmaceutical, biologics, CRO, and clinical sites' 21 CFR Part 11 requirements and software validation principles
- Must be based in the United States
- Visa sponsorship is not available
Benefits:
- Comprehensive benefits supporting physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
- Equity may be included in compensation
- Relocation assistance is not available
- Visa sponsorship is not available
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