Clinical IT Quality Control Analyst - Remote US

Summary

McKesson, through Sarah Cannon Research Institute, advances oncology treatments and improves outcomes for cancer patients through clinical research. The Clinical IT Quality Control Analyst oversees quality control and assurance for software, process, and data integrity validation, while supporting compliance with GxP, 21 CFR Part 11, and regulatory requirements.

Responsibilities

• Provides support to research operations and IT on the interpretation of corporate and regulatory requirements (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 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy
• Provides support of 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 with SOPs, corporate policies, standards, and government regulations
• Provides quality review of related to changes that impact validated systems and/or processes
• Other duties as assigned

Skills

• Bachelor's Degree required; professional qualified experience may be substituted for education
• Direct experience in QA/QC role in computerized systems validation
• 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
• 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
• Experience in GCP clinical space, such as CRO or SMO, is highly preferred
• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred

Qualifications

Must Haves

• Bachelor's Degree required; professional qualified experience may be substituted for education
• Direct experience in QA/QC role in computerized systems validation
• 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
• 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

Nice to Haves

• Experience in GCP clinical space, such as CRO or SMO, is highly preferred
• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred

Benefits

• Remote position based in the US
• A Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
• An annual bonus may be offered
• Long-term incentive opportunities may be offered