[Hiring] Clinical IT Quality Control Analyst @Sarah Cannon Research Institute

Role Description

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 ensure compliance 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.

This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Responsibilities

• Provides support to research operations and IT on the interpretation of corporate and regulatory requirements related to software validation, quality management, and GxP.
• Oversees quality activities related to software, process, and data integrity validation.
• Reviews validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports.
• Ensures completeness and accuracy in adherence with SOPs, corporate policies, standards, and government regulations.
• Supports quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
• Assists with periodic review of system documentation according to defined schedule to ensure continued compliance.
• Provides quality review related to changes that impact validated systems and/or processes.
• Other duties as assigned.

Qualifications

• 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 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 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.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package determined by performance, experience, skills, equity, and geographical markets.
• Potential for additional compensation, such as an annual bonus or long-term incentive opportunities.

Company Description

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.