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.
- 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