Quality Control Analyst

Agilent TechnologiesBoulder, CO
22h$34 - $53

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. Conducts routine and non-routine analysis and reviews of analytical data for raw materials, in-process, microbiology/ cleaning validation program and other requested testing according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Completes projects to with supervision. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, 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

  • Bachelor's of Science
  • Two years experience in Analytical Chemistry or related life sciences field industry experience and/or training; or equivalent combination of education and experience.
  • Knowledge of cGMP guidelines as well as international regulations

Nice To Haves

  • Knowledge of analytical equipment and instrumentation: HPLC, UV, PH, Karl Fisher moisture testing
  • Knowledge of FDA regulations and guidelines
  • Proven skills in coordinating and managing day to day tasks and working in collaboration
  • Knowledge of computer software and hardware applications, including Microsoft Word and Excel
  • Personal leadership skills and working in a team environment

Responsibilities

  • Communicate directly with project managers and management
  • Conduct 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 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, and reports and troubleshoots abnormalities
  • Ensures equipment is performing well and communicates and takes appropriate action as necessary
  • Required to follow good documentation practices
  • Works cross-functionally to complete projects and testing

Benefits

  • full time weekly schedule
  • eligibility for bonus, stock and benefits
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