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QC Analyst / Stability Program

Company: N/A

Location: Boulder, CO

Pay: N/A

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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 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.


Responsible for Stability Studies Program which includes:



  • Maintains stability sample inventory, initiates pull dates for studies and compiles finished testing and results.

  • Works with project management to write protocols and reports for routine and non-routine stability studies

  • Supports updating SOP's (Standard operating procedures), analytical methods and reference documents.

  • Responsible for writing and executing CAPA's (Corrective and preventative actions), Change controls and laboratory investigations.

  • Responsible for packaging bulk product

  • Acts as a backup for Sample Management; maintains contract laboratory sample send-outs, testing and results.

  • Reviews stability reports against data generated in quality control (QC).

  • Has a clear understanding of Good manufacturing practices (cGMPS) and international regulatory requirements. Actively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalates issues to QC management.


ESSENTIAL DUTIES AND RESPONSIBILITIES: includes the following:


*Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management.


*Supports stability program clients associated with clinical and commercial studies 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.


*Reviews data for compliance to specifications, protocols and reports and troubleshoots abnormalities.


*Required to follow good documentation practices.


*Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.


SHIFT HOURS: 8:00am-5:00pm M-F



Job Requirements