Remote IT QC Specialist - Clinical Software Validation

Sarah Cannon Research Institute; Tennessee; On-site; USD 85,000 - 120,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist to oversee software validation, quality management, and data integrity validation in a remote US-based role. You will collaborate with Global Quality, IT QC Specialists, Validation Specialists, Product Owners, and Analysts to ensure regulatory compliance (GxP, 21 CFR Part 11).

The role requires a Bachelor's degree and 3+ years in a clinical research or pharma environment focused on FDA GxP requirements.

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 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/regulatory requirements related to software validation, quality management, and GxP.
• Reviews validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports.
• Supports quality guidance through cycle of preparation, execution, data analysis, and report writing for IQ/OQ/PQ protocols.
• Assists with periodic review of system documentation to ensure continued compliance with SOPs and regulations.
• Provides quality review of changes that impact validated systems and/or processes.
• Other duties as assigned.

Education

Bachelor's Degree

Tools

GxP

21 CFR Part 11

Quality Assurance

Job description

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist to oversee software validation, quality management, and data integrity validation in a remote US-based role. You will collaborate with Global Quality, IT QC Specialists, Validation Specialists, Product Owners, and Analysts to ensure regulatory compliance (GxP, 21 CFR Part 11).

The role requires a Bachelor's degree and 3+ years in a clinical research or pharma environment focused on FDA GxP requirements.