Quality Assurance Systems Specialist

Location: Bend, OR - Lonza

Employment Type: Contract

Work Schedule: On-site

Position Summary

We are seeking a Senior Quality Assurance Specialist and Site Data Integrity Lead to support equipment qualification, computerized systems validation, and data integrity initiatives in a pharmaceutical/biotechnology environment.

This role provides quality oversight for commissioning, qualification, and validation activities while strengthening the site’s data integrity practices. The successful candidate will collaborate with Quality Assurance, Quality Control, IT, Automation, and vendors to maintain compliant systems and documentation.

Key Responsibilities

• Support commissioning and qualification (C&Q) and computerized systems validation (CSV) projects.
• Author, execute, review, and approve validation protocols, reports, and system lifecycle documents.
• Review and approve qualification and validation deliverables for equipment, analytical instruments, and computerized systems.
• Serve as a subject matter expert to promote consistent validation strategies for equipment, systems, and methods.
• Perform assessments supporting change control and risk management.
• Assist with system troubleshooting and staff training.
• Support investigations, root cause analysis, and corrective and preventive actions (CAPAs).
• Participate in client audits and regulatory inspections.
• Lead site data integrity (DI) initiatives, promote awareness, and improve site DI maturity.
• Establish and facilitate a site DI forum covering remediation activities, CAPAs, training, best practices, deviations, and inspection preparation.
• Conduct regular DI Gemba walkthroughs to assess practices where work is performed and identify potential risks.
• Work with stakeholders to resolve findings, address assessment gaps, and reduce data integrity risks.

Required Qualifications

• Bachelor’s degree in a scientific discipline.
• At least five years of experience in the pharmaceutical, biotechnology, or a related industry, including at least two years within a quality unit.
• Experience with equipment qualification, analytical instrument qualification, and computerized systems validation.
• Working knowledge of GxP requirements, 21 CFR Part 11, EU GMP Annex 11, and applicable industry standards, including USP.
• Ability to author, review, and approve controlled documents and validation records.
• Ability to collaborate across technical and quality functions and provide guidance on validation issues.

Work Requirements

• Use personal protective equipment as required.
• Perform occasional light lifting of less than 25 pounds.
• Travel as needed.

Apply

Please submit your resume highlighting your experience in quality assurance, equipment and analytical instrument qualification, computerized systems validation, and data integrity.