Kaiya Densa Email & Phone Number

Los Angeles, CA, US

Pomona, California, United States

• Support all activities for the Quality Operations and Compliance groups.
• Review and approve Production Batch Records, process validations, QC test protocols and other controlled documents, and verify that products are manufactured in accordance with relevant procedures and regulations.
• Review and approve manufacturing and QC laboratory investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Author, review and approve gap assessments and risk assessments.
• Establish procedures to ensure data integrity is maintained and procedures/processes are compliant.
• Ensure appropriate deviations and CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

• Developed and implemented Microbiology testing program, including development of assays, SOPs, and training programs.
• Subject Matter Expert for Endotoxin, Subculture, Media and Organism Suitability, and Environmental Monitoring programs.
• Execution of ISO 5 – ISO 8 Environmental Monitoring of cleanrooms, facility & personnel.
• Performance, review and troubleshooting of microbiological assays including Endotoxin, Sterility, Mycoplasma and Bioburdentesting, Microbial Identification, Subculturing, Growth Promotion, Media/Organism Suitability, &.
• Performance, review, and approval of release testing of Final Product.
• SOP and document creation, revision, review, and approval, extensively through Veeva.

Thousand Oaks, California, United States

-Responsible for providing Environmental Monitoring and aseptic practices training to 90% of Technical Operations at all US InstilBio locations. (Thousand Oaks, CA/ Tarzana, CA/ Philadelphia, PA/ Chicago, IL)-Subject Matter Expert for EM program testing, including Risk Assessment, EMPQ and routine testing in compliance with regulatory requirements and.

Los Angeles, California

-Promoted from Sr. Analyst to Lead Analyst in August 2021: Manage work flow in microbiology lab, train colleagues, daily communication with other departments, directed team on how to proceed with testing, delegated tasks, troubleshooted results, participated in daily meetings with management regarding shift handoff.-Perform testing & collection associated.

Westlake Village, California

-Upheld the Four Seasons’ 5 Diamond service standard while providing an exceptional fine dining experience. Anticipate guest needs, ascertain satisfaction, and respond urgently and appropriately to guest concerns and requests. Requires high level of professionalism, patience, and proactivity. Banquet events include weddings, Bar/Bat Mitzvahs, company.

Greater Los Angeles Area

As a Laboratory Technician in the Genetic Analysis and Molecular Biology departments, my responsibilities included:-Processed sequencing template, including: preparation, amplification and PCR purification.-DNA plasmid preparation of various prep sizes.-Performed plasmid transformation and restriction digest of DNA preps.-Perform routine maintenance of DNA.

Responsible for walking, feeding and caring for customers’ pets, including cats, dogs, fish, etc. Requires a high level of compassion, patience and trust. Numerous clients and references.