QC Analyst III

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