QC Scientist: Compendial & Analytical Quality (Bend, OR)

Lonza Biologics, Inc.; Bend (OR); On-site; Confidential; Full time

Benefits offered by this job

Day-One Insurance: Life, disability, &

401k Match: 100% up to 6%

Lonza bonus program

Job summary

Lonza Biologics, Inc. in Bend, OR seeks a QC Scientist – Compendial & Analytical Quality to review and update internal documentation based on compendial changes and ensure QC compliance with pharmacopeial monographs. The role coordinates all testing activities with external contract laboratories to ensure outsourced data meets Lonza standards.

The position is site-based, enabling close collaboration and precise execution to ensure medicines meet highest quality and safety standards.

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific field.
• 3 to 5 years of hands-on experience 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, shipping samples, and reviewing external data.
• Proficiency in analytical methods such as HPLC, GC, UV-Vis, FTIR, titration; strong technical writing for SOPs and data integrity.

Responsibilities

• Data & Report Authorization: Evaluate and authorize analytical raw data, lab notebooks, and reports to ensure data integrity and compliance.
• Compendial Monitoring: Monitor and implement compendial updates to align with regulatory standards.
• Document Lifecycle Management: Oversee end-to-end lifecycle of controlled documents, records, and material specs.
• Technical Authoring & Review: Author, review, and approve SOPs, analytical methods, and validation protocols.
• Investigations & Root Cause Analysis: Lead and support laboratory investigations and root cause analyses.
• External Testing Oversight: Manage end-to-end external testing, liaising with CROs on timelines and method feasibility.
• Procurement Coordination: Coordinate procurement, including POs for external testing services and lab consumables.

Skills

GxP knowledge

Regulated lab

Documentation

Analytical methods

Data integrity

Education

Bachelor's degree in Chemistry/Biology/Biochemistry

Tools

HPLC

GC

UV-Vis

FTIR

Titration

Job description

Lonza Biologics, Inc. in Bend, OR seeks a QC Scientist – Compendial & Analytical Quality to review and update internal documentation based on compendial changes and ensure QC compliance with pharmacopeial monographs. The role coordinates all testing activities with external contract laboratories to ensure outsourced data meets Lonza standards.

The position is site-based, enabling close collaboration and precise execution to ensure medicines meet highest quality and safety standards.