Sarah Cannon Research Institute · 12 hours ago
Sr. IT Quality Control Specialist - Remote US
United States
Full-time
Remote
Mid, Senior Level
3+ years expSarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing cancer treatments. The Senior IT Quality Control Specialist oversees quality control and assurance of software and data integrity validation processes, providing guidance to operational teams to ensure compliance with regulatory requirements.
Responsibilities
Provides expert guidance to research operations and IT teams on interpreting corporate and regulatory requirements (standards, policies, and procedures) related to software validation, quality management, and GxP compliance, and oversees quality activities supporting software, process, and data integrity validation
Reviews validation lifecycle documentation—including validation assessments, 21 CFR Part 11 evaluations, system validation plans, risk management plans, and validation summary reports—to ensure completeness, accuracy, and alignment with SOPs, corporate policies, standards, and applicable regulations
Delivers quality oversight throughout the preparation, execution, data analysis, and reporting phases of IQ, OQ, and PQ protocol development and execution
Conducts or supports scheduled periodic reviews of system documentation to maintain ongoing compliance with SOPs, corporate policies, standards, and regulatory expectations
Performs quality review and approval of change control documentation for changes impacting validated systems and/or processes
Other duties as assigned
Qualification
Preferred
Bachelor's Degree highly preferred; work experience may be substituted for education
3-5+ years' work experience in a clinical research, life sciences, or CRO focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
Experience should include industry and international standards for software quality such as GAMP V, PIC/S, ICH, etc
Experience should include pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principals
Exceptional time management and organizational skills, and experience working as part of a cross-disciplinary team and relating to a diverse number of coworkers
Benefits
Comprehensive benefits to support physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities
Company
Sarah Cannon Research Institute
Sarah Cannon Research Institute is one of the world’s leading oncology research organizations conducting community-based clinical trials.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Deepak Bhamidipati
Assistant Director of Drug Development
Recent News
Company data provided by crunchbase