Quality Assurance Systems Specialist

Katalyst-Healthcares-; Bend (OR); Sur place; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k)

Résumé du poste

Katalyst-Healthcares- seeks a qualified validation specialist to support equipment qualification, analytical instrument qualification, and computerized systems validation, ensuring GxP and 21 CFR Part 11 compliance. The role leads Data Integrity initiatives, drives DI maturity, and collaborates with IT, QC, Automation, QA, and vendors.

The ideal candidate has 5+ years in pharma/biotech, 2+ years in a Quality Unit, and hands-on experience with validation lifecycle documents and DI programs.

Qualifications

• 5+ years in pharmaceutical/biotech or related industry.
• 2+ years in a Quality Unit.
• Experience with equipment and analytical instrument qualification.
• Experience with computerized systems validation.
• Working knowledge of GxPs, 21 CFR Part 11, Annex 11 and USP standards.

Responsabilités

• Support commissioning, qualification and computer system validation projects.
• Write, execute, review and approve validation protocols and reports.
• Collaborate with IT, QC, Automation, QA, and vendors for qualification 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 site-wide.
• Generate, review, and approve controlled documents and records.

Connaissances

Data Integrity

Validation strategy

GxPs knowledge

Process troubleshooting

Stakeholder collaboration

Formation

Bachelor's degree in Science

Description du poste

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.

Roles & 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
• Ad-­hoc 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).