QC Scientist – Compendial & Analytical Quality

Lonza • Bend, OR

3d • Onsite

About The Position

Lonza is looking for a QC Scientist – Compendial & Analytical Quality to join our Quality team in beautiful 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 be responsible for coordinating all testing activities performed at external contract laboratories and ensuring that all outsourced analytical data meets strict regulatory standards and Lonza quality requirements.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
• 3 to 5 years of hands-on specific 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 (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 document based on compendial changes.

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.
• Reviewing and updating internal documentation based on compendial changes.
• Ensuring QC is in compliance with official pharmacopeial monographs.
• Coordinating all testing activities performed at external contract laboratories.
• Ensuring that all outsourced analytical data meets strict regulatory standards and Lonza quality requirements.

Benefits

• Relocation assistance is available for eligible candidates and their families, if needed.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level