Remote Clinical IT QA Specialist — GxP Systems

United States Digital Space LLC; United States; Remote; USD 85,000 - 120,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist for a fully remote role based in the United States. The specialist will ensure software, process, and data integrity validation aligns with GxP and 21 CFR Part 11, collaborating with Global Quality, IT QC Specialists, Validation Specialists, and Product Owners.

Qualified candidates have 3+ years in clinical research or pharma, familiarity with EU Annex 11, and knowledge of GAMP V/ICH standards.

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 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 the 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.
• Review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy.
• Support of 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 according to defined schedule 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 expertise

GxP

21 CFR Part 11

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI) is seeking an IT Quality Control Specialist for a fully remote role based in the United States. The specialist will ensure software, process, and data integrity validation aligns with GxP and 21 CFR Part 11, collaborating with Global Quality, IT QC Specialists, Validation Specialists, and Product Owners.

Qualified candidates have 3+ years in clinical research or pharma, familiarity with EU Annex 11, and knowledge of GAMP V/ICH standards.