Quality Assurance Systems Specialist

Naderi Engineering, Inc.; Bend (OR); On-site; USD 90,000 - 150,000; Full time

Job summary

Naderi Engineering, Inc. seeks a Senior Quality Assurance Specialist and Site Data Integrity Lead to support equipment qualification, CSV, and data integrity initiatives at our Bend site.

The role provides quality oversight for C&Q, CSV, and DI activities, collaborating with QA, QC, IT, Automation, and vendors to maintain compliant systems and documentation.

Qualifications

• Bachelor’s degree in a scientific discipline.
• At least five years in pharmaceutical/biotech, including ≥2 years in a quality unit.
• Experience with equipment qualification, instrument qualification, and CSV.
• Knowledge of GxP, 21 CFR Part 11, EU GMP Annex 11, and USP.
• Ability to author, review, and approve validated records and documents.
• Ability to collaborate across technical and quality functions.

Responsibilities

• Support C&Q and CSV projects and related documentation.
• Author, review, and approve validation protocols and reports.
• Review qualification/validation deliverables for equipment and instruments.
• Lead DI initiatives and promote data integrity maturity.
• Participate in client audits and regulatory inspections.
• Establish DI forum and conduct regular DI walkthroughs.
• Work with stakeholders to address gaps and reduce DI risks.

Skills

Equipment qualification

Analytical instrument qualification

CSV (computerized systems validation)

GxP knowledge

21 CFR Part 11

EU GMP Annex 11

USP

Controlled documents

Validation records

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Job description

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.