Clinical IT Quality Control Analyst

McKesson

IT quality control specialist validating clinical research systems for SCRI, a community-based oncology research organization. Ensuring GxP, FDA, and 21 CFR Part 11 compliance across software and data integrity processes.

Posted 8/15/2026full-timeRemote • Tennessee • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in quality assurance and validation processes within regulated environments, particularly focusing on GxP, 21 CFR Part 11, and FDA software validation guidelines. Proficient in reviewing validation lifecycle documents and providing quality guidance for validation protocols.

Highest-signal resume keywords

Quality Assurance in Computerized Systems ValidationGxP Compliance and FDA RegulationsValidation Lifecycle Document ReviewClinical Research and Biotech ExperienceKnowledge of Software Quality Standards

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality ControlData Integrity ValidationValidation AssessmentsRisk Management PlansIQ, OQ, and PQ ProtocolsSoftware Validation PrinciplesGxP Requirements21 CFR Part 11EU RegulationsGAMP V

Industry Keywords

Clinical ResearchBiotechPharmaceuticalCROSMOPIC/SICHAnnex 11FDA Software Validation GuidelinesRegulatory Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee quality control and assurance of software, process, and data integrity validation processes
Provide guidance and support to operational teams on GxP, 21 CFR Part 11, and regulatory requirements
Work with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts
Support research operations and IT in interpreting corporate and regulatory requirements
Review validation lifecycle documents, including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports
Provide quality guidance for preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
Assist with periodic review of system documentation
Provide quality review of changes affecting validated systems and processes
Perform other duties as assigned

Requirements

What you’ll need

Bachelor's Degree required; professional qualified experience may be substituted for education
Direct experience in a QA/QC role in computerized systems validation
3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused on FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines
Experience in the GCP clinical space, such as CRO or SMO, highly preferred
Experience and knowledge of EU regulations, such as Annex 11, preferred
Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH
Knowledge of pharmaceutical, biologics, CRO, and clinical site 21 CFR Part 11 requirements and software validation principles
Must be based in the US
Relocation assistance and visa sponsorship are not available

Benefits

Comp & perks

Comprehensive benefits supporting physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Resources and opportunities to grow and be your best
Balanced life