Remote Clinical IT Quality Control Analyst

McKesson’s Corporate; Tennessee; Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Total Rewards program

Competitive compensation

Performance bonus

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist for a remote role based in the United States. You will support research operations and IT on software validation, quality management, and GxP compliance across IQ/OQ/PQ activities.

The ideal candidate has a Bachelor's degree and at least 3 years' FDA GxP validation experience in clinical research or biotech, familiarity with 21 CFR Part 11 and Annex 11, plus knowledge of GAMP V and ICH

Qualifications

• Bachelor's Degree required; professional qualified experience may substitute.
• 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 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.
• Reviews validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports according to SOPs and regs.
• Supports quality guidance through preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
• Assists with periodic review of system documentation to ensure ongoing compliance with SOPs and regulatory standards.
• Provides quality review of changes that impact validated systems and/or processes.
• Other duties as assigned.

Skills

QA/QC

GxP

21 CFR Part 11

Clinical research

Regulatory knowledge

Documentation

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking an IT Quality Control Specialist for a remote role based in the United States. You will support research operations and IT on software validation, quality management, and GxP compliance across IQ/OQ/PQ activities.

The ideal candidate has a Bachelor's degree and at least 3 years' FDA GxP validation experience in clinical research or biotech, familiarity with 21 CFR Part 11 and Annex 11, plus knowledge of GAMP V and ICH