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Sr. IT QC Specialist

System One • Nashville, TN • 2h ago

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)

Overview

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.

Responsibilities

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

Qualifications

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

Benefits

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.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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