Location: Remote - Nashville, TN (PST preferred)

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 3 months (possible extension)

Compensation: $54/$62 per hour (based on experience)

Summary of the Role

Join a large biotech pharmaceutical leader as a remote Quality Assurance contractor specializing in Computer Systems Validation (CSV) and change control. You will support GxP computer systems initiatives, ensure documentation compliance, and drive risk-based validation processes. This role directly impacts operational compliance and system integrity within regulated environments.

Key Responsibilities

• Serve as Quality Assurance (QA) contact for Change Control related to computerized systems
• Review and approve validation deliverables including plans, requirements, testing protocols, and summary reports
• Act as a change agent and advocate for the Risk Based Validation program
• Function as subject matter expert (SME) for multiple quality processes, such as Deviations and CAPA
• Review and approve Standard Operating Procedures (SOPs) and related documents
• Conduct periodic reviews for GxP systems
• Perform software supplier evaluations as needed
• Support project initiatives and process improvements
• Present on validation topics or issues to management when required
• Support audits, inspections, and other quality-related duties as necessary

Required Experience & Skills

• Mandatory Computer Systems Validation (CSV) experience
• Experience with validation and change control (risk-based validation and/or Computer System Assurance knowledge highly preferred)
• Strong documentation, operational, and compliance skills
• Proactive, engaged, and professional in handling escalations and de-escalating conflicts
• Excellent written and verbal communication skills
• Strong team collaboration and leadership abilities
• Ability to interpret and apply GMP, GLP, GCP, and GPvP regulations
• Strong organizational skills to see assignments through completion

Preferred Qualifications

• 5+ years’ experience in a regulated industry (e.g., biotechnology, medical device, aerospace) in a similar role
• Experience working with Veeva or safety systems
• Knowledge of industry-wide regulatory systems
• Strong problem-solving and risk assessment abilities
• Demonstrated knowledge of industry and business principles

Top 3 Must Have Skills

1. Prior experience with Computer Systems Validation and risk-based decision making

2. Project management experience (preferred)

3. Ability to evaluate documentation and operations according to company and regulatory guidelines

Day-to-Day Responsibilities

• Review and approve validation documents such as validation plans, specifications, user and functional requirements, testing protocols, summary reports, and traceability matrices
• Review and approve operational and administrative SOPs
• Review and approve change controls as QA contact or owner
• Provide and present risk-based validation training and workshops
• Assist or lead validation strategy and risk-based requirements profiling
• Work independently with minimal supervision

Basic Qualifications

• Doctorate degree
• Master degree and 3 years of experience
• Bachelor degree and 5 years of experience
• Associate degree and 10 years of experience
• High school diploma / GED and 12 years of experience

This posting is for Contingent Worker, not an FTE