Remote Clinical IT QA/QC Analyst — GxP & 21 CFR 11

McKesson Corporation; North Carolina; Remote; USD 90,000 - 120,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist to oversee software validation, data integrity, and quality processes. You will collaborate with Global Quality and Education, IT QC Specialists, Validation Specialists, and Product teams to ensure GxP compliance and 21 CFR Part 11 adherence.

This remote US-based role requires broadened knowledge of FDA guidelines, EU Annex 11 when applicable, and industry standards like GAMP V.

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 (CRO/SMO) preferred.
• 3+ years' experience in clinical research/biotech/pharma focused on FDA GxP and 21 CFR Part 11.
• EU Annex 11 knowledge is preferred.
• Knowledge of GAMP V, PIC/S, ICH, etc.

Responsibilities

• Provides quality control oversight for software validation, data integrity, and process validation.
• Reviews validation lifecycle documents (validation assessments, 21 CFR Part 11 assessments, VMPs, risk management, summaries) for compliance.
• Supports IQ/OQ/PQ protocol preparation, execution, data analysis, and reporting.
• Performs periodic reviews of system documentation to ensure ongoing SOP compliance.
• Reviews changes that impact validated systems or processes for quality impact.
• Other duties as assigned.

Skills

QA/QC experience

GxP compliance

Regulatory guidance

Clinical research knowledge

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist to oversee software validation, data integrity, and quality processes. You will collaborate with Global Quality and Education, IT QC Specialists, Validation Specialists, and Product teams to ensure GxP compliance and 21 CFR Part 11 adherence.

This remote US-based role requires broadened knowledge of FDA guidelines, EU Annex 11 when applicable, and industry standards like GAMP V.