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