Quality Control Microbiology Analyst

Agilent Technologies•Frederick, CO

1d•$34 - $53

About The Position

To protect the health and safety of our employees, contractors, customers and communities, employees in the U.S. and Puerto Rico are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law. 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. The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in 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, lifesaving medicines. Job Description: Conducts routine, non-routine analysis and review to support release, stability testing, Environmental Monitoring, Cleaning Verification per Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMP) and regulatory requirements. Has a clear understanding of Good Laboratory Practices (GLPs), cGMP, and other regulatory requirements. Actively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalates issues to QC management.

Requirements

Outstanding communication skills, both written and oral
Secondary Education with two years of relevant QC experience
Demonstrated knowledge of analytical equipment and instrumentation

Nice To Haves

Bachelor's degree (B.S.)
Knowledge of FDA regulations
Knowledge of cGMP guidelines
Personal leadership skills in a team environment
Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
Familiar with the following laboratory disciplines is highly desired: Bacterial Endotoxin (LAL Analysis) Bioburden (Membrane Filtration Analysis) Total Organic Carbon (TOC Testing) Compressed Gas Monitoring Environmental Monitoring UV Analysis USP <61>

Responsibilities

Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) 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 APIs (developmental and commercial), final product and other requested testing as per written procedures
Review data for compliance to specifications and reports and troubleshoots abnormalities
Ensures equipment is performing well and communicates and takes appropriate action as necessary
Required to follow good documentation practices
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results