Position Overview

Lonza is seeking a site-based Quality Assurance Systems Specialist in Bend for a contingent assignment coordinated by its talent acquisition partner, Randstad. The role leads data integrity practices and validation of computerized systems supporting biopharmaceutical manufacturing. The posting describes limited flexibility to work remotely up to 20% of the time, subject to business needs.

Responsibilities

• Lead site data integrity governance, improvement planning, and cross-functional initiatives.
• Coordinate equipment and laboratory-instrument qualification and computerized system validation.
• Prepare and review validation protocols, results, and lifecycle records.
• Support regulatory inspections and customer audits as a subject matter expert.
• Conduct risk reviews, investigations, and corrective-action work with quality and technical teams.

Qualifications

• Bachelor’s degree in a scientific field.
• At least five years of pharmaceutical or biotechnology experience, including two in a Quality Unit.
• Experience with equipment qualification and computerized system validation.
• Knowledge of GxP requirements, 21 CFR Part 11, Annex 11, and relevant USP standards.

Additional Information

40 hours per week; contingent role. The employer has not published a numeric pay range. Apply through the recruiting page linked below.