Quality Control Analyst

Agilent Technologies•Frederick, CO

4d•$27 - $42•Onsite

About The Position

Agilent Technologies is hiring a Quality Control Analyst for its quality team at a contract API manufacturing facility specializing in nucleic acid chemistries in Frederick, Colorado. The role supports the development and commercialization of nucleic acid therapeutics. The analyst coordinates and performs routine and non-routine testing for process water, environmental, and compressed gas monitoring, as well as cleaning verification for equipment release to support manufacturing. The position involves in-process analysis using UV, HPLC, and HPLC-MS instrumentation; adherence to SOPs, current Good Manufacturing Practices (cGMPs), and other regulatory requirements; and working on complex problems to drive improvement. Occasional evening and weekend work may be required.

Requirements

Bachelor's degree (B.S.) in Chemistry or a related life sciences field.
0–2 years of relevant industry experience.
Exposure to and knowledge of FDA regulations and guidelines.
Knowledge of cGMP guidelines or international regulations, such as ICH Q7.
Knowledge of analytical equipment and instrumentation used for testing in-process samples.
Proficiency with Microsoft Word and Excel.
Ability to support occasional weekend and evening work.

Nice To Haves

Familiarity with ChemStation, HPLC, and UV analysis.
Experience or familiarity with laboratory disciplines supporting raw material and microbiological sample testing; cross-training may be required.

Responsibilities

Exercise judgment within broadly defined practices and policies when selecting methods, techniques, and evaluation criteria.
Communicate effectively in writing and orally with peers and area managers.
Conduct analyses associated with clinical and non-clinical laboratory studies under cGMP regulations and FDA and OECD guidance.
Review data for compliance with specifications, report results, and troubleshoot abnormalities.
Troubleshoot, investigate, and resolve laboratory testing failures.
Drive solutions to improve quality control laboratory programs through corrective and preventive actions.
Ensure equipment performs well and coordinate preventative maintenance.
Ensure good documentation practices are followed.
Perform routine and non-routine testing for process water, environmental monitoring, and compressed gas monitoring.
Conduct cleaning verification testing for equipment release to support manufacturing activities.