Remote Clinical IT Quality Control Specialist

McKesson; Tennessee; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist to oversee software validation, quality management, and data integrity validation in a remote US-based role.

You will review validation documentation, ensure compliance with GxP and 21 CFR Part 11, and collaborate with Global Quality, IT QC Specialists, Product Owners, and Analysts to maintain regulatory standards.

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 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.

Responsibilities

• Provides support to research operations and IT on the interpretation of corporate and regulatory requirements 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

QA/QC experience

GxP compliance

21 CFR Part 11

Clinical research experience

FDA software validation

EU Annex 11 knowledge

GAMP V / PIC/S / ICH

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist to oversee software validation, quality management, and data integrity validation in a remote US-based role.

You will review validation documentation, ensure compliance with GxP and 21 CFR Part 11, and collaborate with Global Quality, IT QC Specialists, Product Owners, and Analysts to maintain regulatory standards.