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# Clinical IT Quality Control Analyst - Remote US

- **Company:** McKesson
- **Location:** Charlotte, NC, United States (Remote available)
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Software Documentation, Software Quality, Data Integrity, Verification and Validation (Software), System Testing, PIC Microcontroller, Computerised Systems, GXP
- **Published:** September 19, 2026
- **Apply:** https://jobs.localjobnetwork.com/apply/add/88373507/1

## About the Role

* 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.

## 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 ensurecompliance 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., What our IT Quality Control Specialist is responsible for:

 * Provides support to research operations and IT on the interpretation of corporate and regulatoryrequirements (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 11assessments, system validation plans, risk management plans, and validation summary reports inadherence with SOPs, corporate policies, standards, and government regulations to ensurecompleteness and accuracy.
 * Provides support of quality guidance through the cycle of preparation, execution, data analysis, and report writingfor IQ, OQ, and PQ protocols.
 * Assists with periodic review of system documentation according to defined scheduleto ensure continued compliance with SOPs, corporate policies, standards, and government regulations.
 * Provides quality review of related to changes that impactvalidated systems and/or processes.
 * Other duties as assigned


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