Clinical IT Quality Control Analyst
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Job Description
IT quality control specialist validating clinical research systems for SCRI, a community-based oncology research organization. Ensuring GxP, FDA, and 21 CFR Part 11 compliance across software and data integrity processes.
Responsibilities:
- Oversee quality control and assurance of software, process, and data integrity validation processes
- Provide guidance and support to operational teams on 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
- 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 for 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 affecting validated systems and 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
- 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 in the GCP clinical space, such as CRO or SMO, highly preferred
- Experience and knowledge of EU regulations, such as 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 site 21 CFR Part 11 requirements and software validation principles
- Must be based in the US
- Relocation assistance and visa sponsorship are 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
- Resources and opportunities to grow and be your best
- Balanced life
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