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Quality Assurance Expert

1 week ago


Newark, California, United States ICONMA Full time

Job Overview:

We are seeking a highly skilled Quality Assurance Expert to provide compliance support and oversight for operational functions at ICONMA. The ideal candidate will possess strong technical writing skills, analytical expertise, and excellent communication abilities.

Key Responsibilities:

  • Provide compliance support and oversight for operational functions, including quality system records, laboratory investigations, deviations, CAPA, and change controls.
  • Conduct thorough investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis.
  • Generate and analyze metrics for operational activities, including laboratory investigations and invalid assays.
  • Author and/or revise controlled documents, such as procedures, methods, work instructions, protocols, and reports.
  • Ensure personnel compliance with corresponding training programs.
  • Perform risk analysis to determine severity and likelihood of recurrence when triaging events and/or conducting investigations.

Required Qualifications:

  • Bachelor's degree in biology, biochemistry, or related pharmaceutical-biotechnology discipline.
  • A minimum of 3 years of work experience within a GMP environment working with small and/or large molecules.
  • Experience with analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV, and HPLC.
  • Solid technical training and troubleshooting experience are essential.
  • Strong understanding of data integrity principles within a GMP environment.
  • Expertise in Microsoft Office applications.

Preferred Qualifications:

  • Master of Science in related field.
  • Expertise in use of Microsoft Office applications.

Salary and Benefits:

The salary range for this position is $90,000 - $110,000 per year, depending on experience.