Remote Clinical IT QA Analyst – Validation & Compliance

McKesson’s Corporate; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist to support research operations and IT in software validation, quality management, and GxP compliance. This is a remote position based in the US, with relocation assistance and visa sponsorship not available.

The successful candidate will review validation life-cycle documents, assist with IQ/OQ/PQ protocols, and ensure continued compliance with SOPs and regulatory standards across FDA GxP

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 on 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 interpretation of corporate and regulatory requirements related to software validation, quality management, and GxP; oversees quality activities related to software, process, and data integrity validation.
• Reviews validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports to ensure completeness and accuracy.
• Supports 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 to ensure continued compliance with SOPs, corporate policies, standards, and government regulations.
• Provides quality review of changes that impact validated systems and/or processes.
• Other duties as assigned.

Skills

QA/QC experience

GxP knowledge

Regulatory compliance

Quality assurance

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist to support research operations and IT in software validation, quality management, and GxP compliance. This is a remote position based in the US, with relocation assistance and visa sponsorship not available.

The successful candidate will review validation life-cycle documents, assist with IQ/OQ/PQ protocols, and ensure continued compliance with SOPs and regulatory standards across FDA GxP