Validation Specialist II

C

CereCore

Validation Specialist II

Nashville, TN
Full Time
Paid
  • Responsibilities

    Classification: Contract

    Contract Length: 4 months

    CereCore is a healthcare solutions provider that specializes in offering IT services, workforce management, and operational support to healthcare organizations. They focus on improving the efficiency and effectiveness of healthcare systems through various solutions, including electronic health record (EHR) support, IT staffing, and consulting services.

    Position Summary

    • BS Required, MS Preferred
    • 3+ years of experience required
    • Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
    • Knowledge of EU regulations, e.g., Annex 11 is helpful.
    • Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful.
    • Pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles
    • Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
    • Knowledge of EU regulations, e.g., Annex 11 is helpful.
    • Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful.
    • Pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles
    • Work closely with ITG Contract Analysts, Contract Managers, and Business Owners, and has regular contact with Project Managers, Financial Analysts, and Procurement, with occasional support to Directors and Executive Management

    Requirements

    • The Validation Specialist II provides subject matter expertise on computer system validation and policies at Sarah Cannon Research Institute (SCRI) and Genospace.
    • The Validation Specialist II supports the validation strategy and policies at Sarah Cannon Research Institute (SCRI) and Genospace.
    • Works with internal and external customers to ensure compliance with applicable regulations.
    • Helps other Validation Specialists and technical team members to ensure successful delivery of the validated system to meet SCRI business need.
    • Authors computer system validation documentation ensuring compliance with applicable regulations.