Remote Clinical IT Quality Assurance Specialist

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

Job summary

Sarah Cannon Research Institute (SCRI) seeks an IT Quality Control Specialist to oversee software, process, and data integrity validation, ensuring compliance with GxP and 21 CFR Part 11. This remote US-based role supports Global Quality and Education and collaborates with IT QC Specialists, Validation Specialists, and Product Owners.

Relocation and visa sponsorship are not available. A Bachelor’s degree and 3+ years in FDA GxP environments are preferred, with strong regulatory knowledge and

Qualifications

• QA/QC experience in computerized systems validation.
• Knowledge of GxP requirements and software validation principles.
• Familiarity with 21 CFR Part 11 and regulatory compliance.

Responsibilities

• Provide guidance on corporate and regulatory requirements for software validation, quality management, and GxP.
• Review validation lifecycle documents (validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, validation summary reports).
• Support IQ/OQ/PQ protocols from preparation to data analysis and reporting.

Skills

QA/QC

GxP

21 CFR Part 11

Software Validation

Regulatory Compliance

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI) seeks an IT Quality Control Specialist to oversee software, process, and data integrity validation, ensuring compliance with GxP and 21 CFR Part 11. This remote US-based role supports Global Quality and Education and collaborates with IT QC Specialists, Validation Specialists, and Product Owners.

Relocation and visa sponsorship are not available. A Bachelor’s degree and 3+ years in FDA GxP environments are preferred, with strong regulatory knowledge and