Mid-Level Quality Control – CSV/Validation Specialist (Remote-US)

We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the life science Industry. 

Location: Candidates can be located anywhere in the U.S but should ensure 3-4 hours of daily overlap with offshore teams.

Job Summary

The Mid-level Quality Control – CSV Specialist will lead the validation of computer systems used across the organization, ensuring compliance with regulatory requirements and upcoming 2025 FDA regulations. This role is critical to maintaining validated systems, supporting audits, and enabling smooth operations in our diagnostics environment

Key Responsibilities

Validation Execution

• Support development of validation deliverables including URS, FRS, Test Scripts, and Validation Summary Reports.
• Execute test protocols aligned with risk-based CSA/CSV methodologies and document results clearly.
• Assist in maintaining traceability and documentation accuracy throughout the validation lifecycle.
• Contribute to system change control and impact assessment processes.

Compliance Support

• Apply principles of FDA’s 2025 CSV/CSA expectations, GxP, and data integrity during daily work.
• Support internal and external audits with validation documentation and system information.
• Perform periodic reviews of validated systems to ensure ongoing compliance.

Cross-Team Coordination

• Collaborate with IT, QA, Operations, and business stakeholders to support system implementation.
• Review vendor documentation and support qualification activities.
  
  

Required Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or equivalent.
• 3–5 years of hands-on experience in CSV/CSA in a regulated environment.
• Understanding of FDA guidelines, 21 CFR Part 11, data integrity, and system lifecycle management.
• Strong documentation skills and ability to follow SOPs and quality processes.
  
  

Preferred Qualifications

• Exposure to FDA’s 2025 CSV/CSA concepts, including critical thinking-based assurance approaches.
• Experience with LIMS, QMS, or other GxP systems.

Familiarity with GAMP 5, 2nd Edition.

Other Job Details:

• Location: Remote
• Candidate rate: : $45 on C2C and $40 on W2
• Docs required: ID proof will be required.

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