Specialist II, Quality Assurance Validation

United States, Bend (Oregon)

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Pharma & Biotech is currently seeking a Specialist II, Quality Assurance for our team in Bend, Oregon. Here, you’ll have the outstanding opportunity to work with world-class professionals in a collaborative environment that fosters innovation and excellence. You’ll play a meaningful role in ensuring our products meet the highest quality standards, helping us to achieve flawless execution.

Key Responsibilities

• Review and approve method validation protocols, summary reports, stability protocols & reports, and related documentation for accuracy, completeness, and compliance with cGMP and regulatory guidelines.
• Act as subject matter expert and ensure consistency in validation strategy/approach for analytical instrument qualification, and method validation.
• Collaborate with Analytical Development, and QC groups to support method development/validation, analytical instrument qualification and lifecycle management of associated documents.
• Review and assist in timely completion of validation discrepancy reports, change controls, investigations, and CAPA/ECs as applicable.
• Participate in internal and external audits, & regulatory inspections providing subject matter expertise on method validation and QA processes.
• Track and trend validation metrics to support continuous improvement initiatives.
• Ensure timely QA oversight of analytical instrument qualification, stability program and method development, transfer & validation activities.
• Knowledge of data integrity principles, system periodic review and audit trail review.
• Controlled documents and records generation, review, and approval in systems like MasterControl, Documentum, Kneat and TrackWise.
• Work with stakeholders to resolve and reduce potential risks from audits and inspection findings, and gap assessments.
  
  

Key Requirements:

• Bachelor’s Degree or equivalent experience in a scientific or related field is required
• Experience in a GMP pharmaceutical or biotechnology industry
• Proven track record with qualification and validation
• Strong attention to detail and ability to work in a fast-paced environment
• Excellent collaboration skills to work effectively across various functions
  
  

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R70491

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