QC Analyst III

Location
94555, Fremont
Posted
Apr 12, 2021
Required Education
Bachelors Degree
Position Type
Contract

This is a six (6) month, contractor assignment. 

 

Description of Duties:

  • Conduct release and stability testing of raw materials, formulations, in-process and finished products according to standard operating procedures.
  • Analyze data and Review data per specifications and reports
  • Participate in lab investigation, CAPA and non-conformance investigations.
  • Revise and update standard operation procedures as needed. 
  • Participate in special projects on analytical and instrument problem solving. 
  • Maintain and order lab supply inventory
  • Applies knowledge of Good Manufacturing Practices and Good Laboratory Practices daily.
  • The QC Analyst will be assigned either day shift or night shift on an as-needed basis.  

 

Position Requirements:

  • BS degree in Chemistry, Biochemistry or equivalent.
  • Minimum of 5-10 years’ experience in QC.
  • Knowledge of HPLC and familiarity with EMPOWER software.
  • Solid knowledge of cGMPs and applicable regulatory ICH, FDA and EMA guidance
  • Familiar with quality systems, such as lab investigation, non-conformance report and CAPA.
  • Ability to work independently and as part of a team; ability to motivate self and others.
  • Good written and communication skills