Quality Assurance Systems Specialist

Katalyst CRO; Bend (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Bend, Oregon seeks a Validation and DI Specialist to lead DI initiatives, qualify equipment, and drive computerized systems validation in support of GxP compliance and 21 CFR Part 11.

You will collaborate with IT, QC, Automation, QA and vendors, write and approve validation documents, support inspections, CAPAs, and promote DI maturity across the site.

Qualifications

• Five+ years in pharma/biotech with QA/validation exposure.
• Experience with equipment and analytical instrument qualification.
• Experience with computerized systems validation.

Responsibilities

• Support commissioning, qualification, and computer system validation projects.
• Write, execute, review, and approve validation protocols, reports, and lifecycle documents.
• Collaborate with IT, QC, Automation, QA, and vendors for qualification and validation activities.
• Perform change assessments and risk assessments.
• Act as SME for validation strategy for equipment, systems, computers, and methods.
• Troubleshoot systems and support staff training.
• Participate in client and regulatory inspections.
• Assist with investigations, root cause analysis, and CAPAs.
• Promote Data Integrity culture and raise DI awareness across the site.
• Improve DI maturity as defined by site/global standards.
• Establish and facilitate DI forum with structured agenda.
• Ongoing DI activities (remediation CAPAs, trainings)
• Sharing best practices and updates from Global
• Sharing site-level DI cases, deviations, and learnings
• Adhoc topics (inspection preparation, etc.)
• Conduct regular DI GEMBA walkthroughs.
• Generate, review, and approve controlled documents and records.
• Supervise validation activities and advise on problem resolution.
• Make decisions related to commissioning, qualification, and validation.
• Work with stakeholders to resolve DI risks and gaps.

Skills

Data Integrity initiatives

GxP compliance knowledge

21 CFR Part 11 & Annex 11

USP standards familiarity

Cross-functional collaboration

Regulatory inspections support

Education

Bachelor's Degree in Science

Job description

Summary

This role supports equipment qualification, analytical instrument qualification, and computerized systems validation. The position ensures compliance with GxPs, 21 CFR Part 11, Annex 11, and USP standards. It also leads Data Integrity (DI) initiatives, improves DI maturity, and drives DI culture across the site. The role collaborates with IT, QC, Automation, QA, and vendors, and participates in inspections, investigations, and CAPAs.

• Support commissioning, qualification, and computer system validation projects.


• Write, execute, review, and approve validation protocols, reports, and lifecycle documents.


• Collaborate with IT, QC, Automation, QA, and vendors for qualification and validation activities.


• Perform change assessments and risk assessments.


• Act as SME for validation strategy for equipment, systems, computers, and methods.


• Troubleshoot systems and support staff training.


• Participate in client and regulatory inspections.


• Assist with investigations, root cause analysis, and CAPAs.


• Promote Data Integrity culture and raise DI awareness across the site.


• Improve DI maturity as defined by site/global standards.


• Establish and facilitate DI forum with structured agenda:


• Ongoing DI activities (remediation CAPAs, trainings)


• Sharing best practices and updates from Global


• Sharing site-level DI cases, deviations, and learnings


• Adhoc topics (inspection preparation, etc.)


• Conduct regular DI GEMBA walkthroughs.


• Generate, review, and approve controlled documents and records.


• Supervise validation activities and advise on problem resolution.


• Make decisions related to commissioning, qualification, and validation.


• Work with stakeholders to resolve DI risks and gaps.

Experience

• Minimum 5 years experience in pharmaceutical/biotechnology or related industry.


• Minimum 2 years experience in a Quality Unit.


• Experience with equipment & analytical instrument qualification.


• Experience with computerized systems validation.


• Working knowledge of GxPs, 21 CFR Part 11, Annex 11, and USP standards.

Education

• Bachelor's Degree in Science (minimum).