QC Scientist – Compendial & Analytical Quality

Location: Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.

About the role

Lonza is looking for a QC Scientist – Compendial & Analytical Quality to join our Quality team in Bend, Oregon. This role will be responsible for reviewing and updating internal documentation based on compendial changes and ensuring QC is in compliance with official pharmacopeial monographs. Additionally, this role will coordinate all testing activities performed at external contract laboratories and ensure that all outsourced analytical data meets strict regulatory standards and Lonza quality requirements. This is a fully site-based role; in-person collaboration supports the technical precision needed to manufacture medicines to the highest quality and safety standards.

Responsibilities

• Evaluate and authorize analytical raw data, laboratory notebooks, and comprehensive test reports to ensure data integrity and compliance.
• Monitor and implement compendial updates to maintain strict alignment with evolving regulatory standards and pharmacopeial requirements.
• Oversee the end-to-end lifecycle of controlled documents, records, and material specifications.
• Author, review, and approve Standard Operating Procedures (SOPs), analytical methods, and validation protocols.
• Lead and support formal laboratory investigations, deviations, and comprehensive root cause analyses.
• Manage the end-to-end process for external laboratory testing, serving as primary liaison for CRO project timelines and method feasibility.
• Coordinate procurement operations, including purchase orders for external testing services and essential laboratory consumables.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
• 3 to 5 years of hands-on experience working in a regulated (cGMP/GLP) pharmaceutical or biopharmaceutical quality control laboratory.
• Deep knowledge of global pharmacopeias (USP, EP, JP, BP) for raw materials and finished products, including verification and execution of monographs.
• Experience coordinating testing with external contract laboratories (CMOs/external labs), shipping samples, and reviewing external data.
• Practical skill with methods like HPLC, GC, UV-Vis, FTIR, titration, and basic wet chemistry.
• Proficient with technical writing for Standard Operating Procedures (SOPs), protocols, and data integrity requirements.
• Ownership of evaluating and updating internal documents based on compendial changes.

Benefits

• Day-One Insurance: Life, disability, and comprehensive health, dental, and vision insurance options.
• 401k Match: 100% match up to 6% of your salary, plus an extra automatic company contribution.
• Lonza bonus program: Performance-linked variable pay plan that rewards yearly company and individual success.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion, and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives.