Quality Control Analyst

Agilent Technologies, Inc.•Frederick, CO

32d•$34 - $53•Onsite

About The Position

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. Agilent Technologies, Inc. is looking to add a Quality Control Analyst to its high-performance quality team working at the state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Frederick, Colorado. The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life-changing, life-saving medicines. This position coordinates and conducts routine and non-routine testing support. Responsibilities include testing to support manufacturing, raw material release, qualification, and validation activities. Understanding and experience with Standard Operating Procedures, current Good Manufacturing Practices (cGMPs) and other regulatory requirements are required. This position will support weekend coverage Friday-Monday (4 x 10 hours, day shift). Position may require QC testing support in both Boulder and Frederick sites.

Requirements

A Bachelor's degree (B.S.) or equivalent in Chemistry or related life sciences field; or equivalent combination of education and experience
2+ years of relevant experience within the Industry
Exposure and knowledge of FDA regulations and guidelines
Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples, raw materials, and microbiological samples
Proficient with Microsoft Word, Excel, and Chemstation
Weekend Shift, consisting of 4 10-hour shifts; must be open to working Thursday thru Sunday or Friday thru Monday on day shift.

Nice To Haves

Familiarity with the following laboratory disciplines is highly desired:
HPLC
Density
HPLC-MS
IC
Solution Preparation
UV analysis
FTIR
Shift Differential for Weekend work

Responsibilities

Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Outstanding communication skills, both written and oral, and the ability to communicate directly with peers and area managers
Conducts analysis associated with clinical and non-clinical laboratory studies under current Good Manufacturing Practices (cGMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as international regulations
Performs analysis on raw materials, in-process materials, APIs (developmental and commercial), final product and other requested testing as per written procedures.
Reviews data for compliance to specifications, report results, and troubleshoots abnormalities
Ensures equipment is performing well and communicates and takes appropriate action as necessary
Troubleshoots, investigates, and resolves laboratory testing failures and drives solutions to improve the quality control laboratory programs through corrective and preventive actions
Maintains inventory and ordering of laboratory supplies
Performs maintenance activities on laboratory instruments and equipment
Ensures good documentation practices are followed