Position Title: Quality Specialist
Location: 17062 Murphy Ave, Irvine, CA 92614
Reports To: QA and Regulatory Officer
Summary of Position:

The Quality Specialist reports the quality assurance activities related to the development and manufacture of products.

Essential Duties and Responsibilities:
  • Conduct activities related to equipment calibration and validation, corrective/preventative actions, non-conformance reports, internal audits, and CAPAs.
  • Perform root cause analysis and implement CAPA.
  • Generate quality documentation and reports by collecting, analyzing and summarizing information and trends for performance measures and quality improvements for management review.
  • Support the design control process and assist with quality assurance activities for new product development.
  • Maintain and improve processes related to final product to ensure manufacturing quality is maintained while efficiency is optimized.
  • Generate and maintain necessary documentation to ensure consistent manufacture of final products.
  • Generate and help maintain new and current employee training.
Skills and Qualifications:
  • A BA or BS degree in Biochemistry, Microbiology, Genetics, Immunology, Virology, Molecular Biology or related field is preferred.
  • 2 or more years minimum with hands on experience with quality management system in Biotechnology or similar field (i.e. ISO9001:2015 or similar).
  • Experience with risk analysis (i.e. FMEA, etc.)
  • Strong verbal and written communication and presentation skills.
  • Self-motivated.
  • Attention to detail and accuracy.
  • Ability to solving problems analytically, creatively and collaboratively.
  • Strong interpersonal and organizational skills.
  • Willingness to learn new things.
  • Visio or similar software experience.
  • Quality Management software experience (preferred).
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