Quality Assurance Specialist - Computer Systems Validation - Remote

Overview

This position involves acting as a Quality Assurance contact for Change Control activities related to Computerized Systems, ensuring compliance with regulatory standards.

In Short

• Act as QA contact for Change Control for Computerized System activities.
• Review and approve validation deliverables.
• Advocate for the Risk Based Validation program.
• Act as SME for multiple Quality processes.
• Review and approve SOPs and associated documents.
• Support project initiatives and process improvements.
• May present topics to management.
• Support audit and inspection requests.
• Collaborate effectively with cross-functional teams.
• Handle escalations and conflicts professionally.

Requirements

• Computer Systems Validation experience is mandatory.
• Ability to interpret and apply GMP, GLP, and GCP regulations.
• Strong documentation and operational compliance experience.
• Excellent communication skills.
• Proactive and engaged team player.
• 5+ years’ experience in regulated industries preferred.
• Master’s or Bachelor’s degree in a technical field or equivalent experience.
• Strong organizational skills.
• Ability to lead and influence teams.
• Experience with Veeva or Safety Systems is a plus.

Benefits

• Competitive pay rate based on experience.
• Opportunity to work in a remote environment.
• Engagement in meaningful projects in regulated industries.
• Collaboration with cross-functional teams.
• Professional development opportunities.