QA Technician/Associate

Location: Tustin, CA.
Job Type: Temp-to-Hire.

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Reports to: QA and Regulatory Officer

Summary of Position:

The Quality Assurance Technician/Associate supports the quality assurance activities related to the development and manufacture of products.


Job Duties:

The job duties include but are not limited to the following :

  • Conducts activities related to equipment calibration and validation, corrective/preventative actions, non-conformance reports, internal audits, and CAPAs.
  • Perform root cause analysis and implement CAPA.
  • Generates quality documentation and reports by collecting, analyzing and summarizing information and trends.
  • 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
  • Maintenance of Quality Assurance documentation
  • Generate and maintain necessary documentation to ensure consistent manufacture of final products.
  • Responsible for quarantine of non-conforming product.


Skills and Qualifications:

  • A BA or BS degree in Biochemistry, Microbiology, Genetics, Immunology, Virology, Moleacular Biology or related field
  • 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)
  • 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
  • Vision or similar software experience
  • Quality Management software experience (preferred)

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