QC Scientist: Compendial & Analytical Quality

Lonza; Bend (OR); On-site; Confidential; Full time

Benefits offered by this job

Day-One Insurance: Life, disability, &

401k Match: 100% up to 6% of salary, +

Lonza bonus program: Performance‑based

Site-based work in Bend, Oregon

Job summary

Lonza in Bend, Oregon is seeking a QC Scientist – Compendial & Analytical Quality to join our Quality team. You will review and update internal documentation based on compendial changes and coordinate analytical testing with external contract laboratories.

This fully site-based role emphasizes data integrity, regulatory alignment, and the timely delivery of compliant test results, SOPs, and method validations, supporting Lonza's mission to manufacture medicines to the highest quality and safety

Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field.
• 3–5 years of hands-on experience in a regulated (cGMP/GLP) pharmaceutical or biopharmaceutical quality control laboratory.
• Deep knowledge of USP, EP, JP, BP pharmacopeias for raw materials and finished products.
• Experience coordinating testing with external contract labs and reviewing external data.
• Proficiency with analytical methods including HPLC, GC, UV-Vis, FTIR, titration.
• Proficient technical writing for SOPs, protocols, and data integrity.
• Ownership of evaluating and updating internal documents based on compendial changes.

Responsibilities

• Data & Report Authorization: Evaluate and authorize analytical raw data, laboratory notebooks, and comprehensive test reports to ensure data integrity and compliance.
• Compendial Monitoring: Monitor and implement compendial updates to maintain strict alignment with evolving regulatory standards and pharmacopeial requirements.
• Document Lifecycle Management: Oversee the end-to-end lifecycle of controlled documents, records, and material specifications.
• Technical Authoring & Review: Author, review, and approve SOPs, analytical methods, and validation protocols.
• Investigations & Root Cause Analysis: Lead and support formal laboratory investigations, deviations, and comprehensive root cause analyses.
• External Testing Oversight: Manage the end-to-end process for external laboratory testing, serving as primary liaison for CRO project timelines and method feasibility.
• Procurement Coordination: Coordinate procurement operations, including purchase orders for external testing services and essential laboratory consumables.

Skills

Data integrity

Regulatory compliance

External testing coordination

Analytical methods (HPLC, GC, UV-Vis,

FTIR and titration

Technical writing

Document control

Education

Bachelor’s degree in Chemistry or related field

Tools

HPLC

GC

UV-Vis

FTIR

Titration

Wet chemistry

Job description

Lonza in Bend, Oregon is seeking a QC Scientist – Compendial & Analytical Quality to join our Quality team. You will review and update internal documentation based on compendial changes and coordinate analytical testing with external contract laboratories.

This fully site-based role emphasizes data integrity, regulatory alignment, and the timely delivery of compliant test results, SOPs, and method validations, supporting Lonza's mission to manufacture medicines to the highest quality and safety