Lonza is looking for Quality Systems Quality Assurance Specialist – Biopharmaceutical in Bend, OR.
This local job opportunity with ID 3939335105 is live since 2026-11-03 17:21:59.
Lonza is seeking a Quality Assurance Systems Specialist to support GMP-compliant quality systems for biopharmaceutical development and manufacturing. In this role, you will manage electronic quality systems, including documentation, deviations, CAPAs, and change controls, while ensuring alignment with FDA, EMA, and ICH requirements. You will review batch records and data, support validation and risk assessments, and contribute to quality metrics and continuous improvement. Working closely with cross-functional teams, you will help prepare for audits and inspections and promote Lonza’s culture of innovation, safety, and patient-centric quality. Support implementation and maintenance of quality systems for biopharmaceutical development and manufacturing Author, review, and manage GMP documentation, deviations, CAPAs, and change controls in electronic quality systems Execute risk assessments and support qualification/validation activities for equipment, utilities, and computerized systems Perform data reviews, batch record assessments, and trend analyses to ensure product and process compliance Collaborate with manufacturing, QC, engineering, and regulatory teams to resolve quality issues and drive continuous improvement Ensure alignment with FDA, EMA, and ICH guidelines and internal quality standards Participate in internal and external audits, inspections, and customer quality reviews Support training and guidance on quality procedures, data integrity, and compliance expectations Contribute to quality metrics reporting, investigation closure, and process optimization projects Promote a culture of safety, quality, and patient-centric outcomes across cross-functional teams GMP compliance and regulatory knowledge (FDA, EMA, ICH) Electronic Quality Management Systems (eQMS) administration and use Deviation, CAPA, and change control management Batch record and data review for GMP operations Validation and qualification documentation (IQ/OQ/PQ) Risk assessment and root cause analysis methodologies Technical writing for SOPs, protocols, and reports Data analysis and quality metrics trending Audit preparation and support (internal, external, and regulatory) Cross-functional collaboration and stakeholder communication Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k GMP training and demonstrated understanding of FDA/EMA regulations Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, or similar Familiarity with validation and qualification principles (IQ/OQ/PQ) for GxP systems Knowledge of ICH, USP, and relevant global regulatory guidelines Six Sigma, Lean, or continuous improvement training (preferred) ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) (preferred)5c143e31-5e48-4549-b638-05792d185386
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