Clinical IT Quality Control Analyst - Remote US

The IT Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. Provides guidance and support to operational teams within Sarah Cannon Research Institute to ensurecompliance with GxP, 21 CFR Part 11, and regulatory requirements. Works closely and effectively with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts., What our IT Quality Control Specialist is responsible for:

• Provides support to research operations and IT on the interpretation of corporate and regulatoryrequirements (standards/policies/procedures) related to software validation, quality management,and GxP and oversees quality activities related to software, process, and data integrity validation.
• Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11assessments, system validation plans, risk management plans, and validation summary reports inadherence with SOPs, corporate policies, standards, and government regulations to ensurecompleteness and accuracy.
• Provides support of quality guidance through the cycle of preparation, execution, data analysis, and report writingfor IQ, OQ, and PQ protocols.
• Assists with periodic review of system documentation according to defined scheduleto ensure continued compliance with SOPs, corporate policies, standards, and government regulations.
• Provides quality review of related to changes that impactvalidated systems and/or processes.
• Other duties as assigned

• Bachelor’s Degree required; professional qualified experience may be substituted for education.
• Direct experience in QA/QC role in computerized systems validation
• Experience in GCP clinical space, such as CRO or SMO, is highly preferred
• 3+ years’ professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred.
• Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc.
• Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles.

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It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world., Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.