Hybrid Computer Systems Validation Analyst III

at Altasciences

• Job title: Computer Systems Validation Analyst III
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: SDLC
• Location requirements: Hybrid, Kansas City, United States

About the role

• Validation Analyst III ensuring compliance of computerized systems at Altasciences. Involves validation processes, regulatory audits, and collaboration across departments.

Responsibilities

• Author, execute, monitor and/or review Validation documents such as: Risk Assessments, Validation Plans, Test Scripts (IQ/OQ/PQ), Traceability Matrix, and Validation Reports per Standard Operating Procedures (SOPs)
• Work closely with internally assigned departments and externally with software vendors and/or contractors, regulatory audit teams and other service providers to facilitate implementation, testing and application of validation principles throughout the implementation process
• Train interdepartmental teams on basic GDP compliance with respect to CSV practices
• Demonstrate mid-level technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance
• Ensure adherence to change management procedures for validated systems
• Conduct technical assessments (e.g., Periodic Review) for validation compliance and impact
• As applicable, maintain inventories, lists, status, and other tracking tools of approved validation documentation, system configuration, and change control
• Possess and understand the key aspects of IT including: networking, LAN, WAN, Computers (servers and workstations) as well as several COTS software systems
• Contribute to the development and maintenance of the validation quality management system (e.g., Master Plan, CSV SOPs)
• Respond to internal/external audit findings and contribute to corrective actions as needed
• Participate in client audits and/or Quality Assurance Department activities during regulatory CSV internal/external audits
• Present and support the validation quality management system towards clients and agencies, as required
• Coordinates activities between ITOPS and Development to ensure CSV project delivery
• Can design, develop and implement workarounds to software or process compliance failures
• Understands laboratory workflows and adapts software as well as processes for GxP compliant operation for several pharmaceutical/CRO software systems

Requirements

• Bachelor's degree in IT, Science, or related field
• 5 years experience in computerized system validation in a regulated environment
• Knowledge of MS Office suite and software testing tools (Rational Visual test)
• Basic knowledge of software development SDLC design standards and standard testing
• Wide knowledge in COTS software systems used in Pharmaceutical/CRO industry with equivalent Laboratory process and systems knowledge
• English (written and spoken)

Benefits

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable
• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Reviews