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QC Analyst II, In-process (2nd Shift)

Organization
Agilent
Job Location
5555 Airport Blvd
Boulder, CO 80301
United States
Job Description

Job Description

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 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.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: QC Analyst

  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management.
  • 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 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.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Personal leadership skills and fosters working in a team environment.

 SHIFT: This position will be on the 2nd shift (2:30 pm - 11:00 pm), Monday - Friday.

Requirements

Qualifications

Qualifications:

  • Bachelor's degree (B.S.) or equivalent experience in Analytical Chemistry or related life sciences field with 2+ years related experience and/or training; or equivalent combination of education and experience.
  • 2+ years of relevant quality control experience
  • Proven knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support the production of APIs, stability, and drug product release.
  • Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred.
  • Knowledge of FDA regulations and guidelines.

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