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Q.C. Specialist III

Mountain View, CA · Biotech/Pharmaceutical
Quality Control Specialist III
Mountain View, CA 94043
Pay Rate: 39/hr. DOE
M – F / 3 month contract to hire! 
Start date: ASAP
 

About the Company:
Our client is a leading venture backed pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Their products are designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. This is a great opportunity to get introduced to a growing Bay Area Pharma company and learn new processes

Responsibilities:
  • Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance of QC test data.
  • Verify data transfer, calculations and documented information such as reagent expiry, instrument calibration, logbook entries, standards, controls, etc. are present, complete and accurate.
  • Verify that all analysis performed were as per test method and/or compendial methods, and were in compliance with GMP requirements
  • Data review included but limited to QC testing data supporting product release, incoming material testing; stability studies, and qualification/validation/verification related studies and laboratory equipment logbooks.
  • Complete training for test methods in timely manner.
  • May participate in investigation related to QC testing, root cause analysis, and deviation reporting, etc.
  • Generate new and /or revise existing department related SOPs
  • Conduct periodic informal laboratory audits to ensure inspection readiness of the labs
  • Organize and track QC analyts’ training records for compliance to department SOPs and project test methods
  • Utilize knowledge of good documentation practices and good laboratory practices on a daily basis.
  • Other duties as assigned
Skills Required:
  • Must be highly organized, detail oriented and able to manage multiple projects
  • Able to maintain detailed and accurate records
  • Excellent communication skills both written and oral
  • Motivated and flexible to work in a dynamic group
  • Must work with a balance of both speed and accuracy.
  • Capable of working independently
  • Ability to remember and accurately follow detailed instructions
Education and Experience:
  • BS degree in scientific area or equivalent
  • 3-5 years of pharmaceutical experience
  • 2+ years performing data review.
  • USP and GMP experience
  • QA experience reviewing documentation
  • Advanced knowledge of analytical methods and testing and related instrumentation.
  • Advanced knowledge of GMPs, safety regulations and data integrity
Please submit resume for consideration!
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