Quality Control Analyst

Agilent Technologies•Frederick, MD

2d•Onsite

About The Position

Agilent Technologies is seeking a Quality Control Analyst for its contract API manufacturing facility in Frederick, Colorado, which specializes in nucleic acid chemistries. The role supports the development and commercialization of nucleic acid therapeutics and is part of the facility’s quality team. The analyst coordinates and performs routine and non-routine testing for process water, environmental, and compressed gas monitoring, as well as cleaning verification to release equipment for manufacturing. The position works under current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements, and uses analytical instrumentation for in-process analysis, including UV analysis, HPLC, and HPLC-MS. It also involves troubleshooting complex problems and improving laboratory quality programs. Occasional weekend and evening work may be required. The position is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m. and is full-time, with no end date. Occasional travel is required. The stated full-time equivalent pay range is $27.15–$42.43 per hour, with eligibility for bonus, stock, and benefits.

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.
Outstanding written and oral communication skills.
Ability to support occasional weekend and evening work.

Nice To Haves

Familiarity with ChemStation.
Familiarity with HPLC.
Familiarity with UV analysis.

Responsibilities

Exercise judgment within broadly defined practices and policies to select methods, techniques, and evaluation criteria for obtaining results.
Conduct analyses associated with clinical and non-clinical laboratory studies under cGMP regulations and guidance from the FDA and OECD.
Coordinate and perform routine and non-routine testing for process water, environmental, and compressed gas monitoring.
Perform testing to support cleaning verification and equipment release for manufacturing activities.
Review data for compliance with specifications, report results, and troubleshoot abnormalities.
Troubleshoot, investigate, and resolve laboratory testing failures; drive improvements to quality control laboratory programs through corrective and preventive actions.
Ensure equipment performs well and coordinate preventative maintenance.
Ensure good documentation practices are followed.
Communicate directly with peers and area managers, both orally and in writing.
May cross-train to test raw material and microbiological samples.
May work with highly potent APIs.