Sr. IT QC Specialist

Job Title: Senior IT Quality Control Specialist – CSV/CSA
Location: 100% Remote (CST preferred)
Hours/Schedule: Monday–Friday, standard business hours
Compensation: $43-47/hour DOQ
Type: Contract (12 months)

The Senior IT Quality Control Specialist provides QA oversight for computerized systems validation (CSV), remediation initiatives, and software quality processes within a regulated environment. This role ensures compliance with FDA CSA principles, GxP requirements, and global regulatory standards while partnering cross-functionally with IT, validation, and operational teams. The ideal candidate is a detail-oriented quality professional with strong regulatory knowledge and hands-on validation lifecycle experience.

• Provide QA oversight for computerized systems validation (CSV), remediation initiatives, and data integrity programs

• Interpret and apply FDA GxP, 21 CFR Part 11, and CSA guidance to validation and quality management processes

• Review validation lifecycle documentation including validation assessments, Part 11 assessments, validation plans, risk assessments, and summary reports

• Provide quality guidance for IQ, OQ, and PQ protocol preparation, execution, data analysis, and reporting

• Conduct periodic reviews of validated systems to ensure continued compliance with SOPs and regulatory requirements

• Review and approve change control documentation impacting validated systems and processes

• Support sponsor audits, regulatory inspections, and quality assessments, including preparation and follow-up activities

• Contribute to development and revision of IT standards, policies, procedures, templates, and QMS documentation

• Educate and mentor staff on validation processes, quality systems, and regulatory expectations

• Monitor emerging FDA guidance and industry standards; assess impact and support implementation of process updates

• Collaborate with validation engineers, business owners, and IT stakeholders to ensure compliant and efficient system validation practices

Required:

• Bachelor’s degree (Master’s preferred) in a scientific, technical, or related discipline

• 5 years of experience in QA oversight within computerized systems validation (CSV)

• Hands-on experience conducting periodic reviews of validated systems

• Strong working knowledge of FDA Computer Software Assurance (CSA) principles

• In-depth knowledge of FDA GxP requirements, 21 CFR Part 11, and software validation guidelines

• Experience supporting remediation initiatives in regulated environments

• Strong analytical, documentation, and technical writing skills

Preferred:

• Knowledge of EU Annex 11 requirements

• Familiarity with GAMP 5, PIC/S, ICH, and other international software quality standards

• Experience in pharmaceutical, biologics, CRO, or medical device environments

• Demonstrated ability to mentor and guide cross-functional teams on validation and compliance best practices

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.