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.• Support FDA audits and inspections in various capabilities.• Work with manufacturing and laboratory management to ensure activities comply with regulatory requirements.• Review proposed changes to systems, procedures, and methods.• Perform quality review of GMP and Quality System issues, non-conforming materials, and CAPA, as needed.• Notation of technical/scientific attributes in potential situations/issues and processing of science-based solutions across job function.

• 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, & Plate Reading.• Performance, review, and approval of release testing of Final Product.• SOP and document creation, revision, review, and approval, extensively through Veeva.• Data entry & trending, preparation of quarterly reports, and presentation of data to management.• Performance of investigations regarding OOS, Action, and Alert level results & Deviations.• Interface daily with & provide support to cross-functional groups, including Manufacturing, Facilities, and Quality Assurance.• Authored and qualified the Endotoxin Testing Program at ImmPACT Bio.• Responsible for ILT/OJT training of all ImmPACT Bio personnel on Environmental Monitoring execution and cleanroom gowning.• Executed and lead EMPQ of cleanrooms and APS of manufacturing process.

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 commitments for clinical products, reporting and investigation of OOS/OOL results, deviations and CAPAs, and EM data trending.-SOP and document creation, revision, review, and approval.-Execution of laboratory assays, including sterility, bioburden and endotoxin testing.-Responsible for booking and coordinating all sample shipments between each InstilBio site and contract testing labs.-Interface daily with & provide support to cross-functional groups, including Manufacturing, Facilities, Supplier Quality, and Quality Assurance.-Qualified to perform nearly all QA functions, including Raw Material release, Master Batch Record review, approval and release, controlled document reviews and approvals, Investigational Product receipt and transfer, and performance of internal audits.-Routinely completed and volunteered to perform tasks delegated to my supervisor and director.-Key contributor to contamination investigation.-One of only 2 Senior QCA’s in the Microbiology department.

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 with bioburden analysis, microbial & particulate monitoring of clean rooms, endotoxin, TOC, conductivity, and pH testing, and reading of microbial plates & interpretation of test results.-Identification, issuance and conduction of investigations into Alert/Action/OOL excursions. Investigation of deviations, utilizing problem-solving tools.-Use of Global LIMS for entering and approving test results. -Support execution of validations and protocols for lab equipment, lab methods, and facility projects.-Qualified Trainer - Provide training and work direction for assigned functional areas. -Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Assure SOPs are updated; prepare and update as determined.-Drive Lean principles such as 5S throughout daily work activities.-Voluntarily completed Chemical Inventory project for all chemicals on-site for EHS. (Completed: September 2020)-Emergency Response Team member since September 2019Relevant skills: 40-hour HAZWOPER, CPR/AED/First Aid, Fire Safety, SCBA, Confined Space-Quality Control Lab Safety Representative & Microbiology EHS Ambassador-Planning Committee member of LGBTQ+ group TakePride since March 2019-Member of the mentorship program since June 2019

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 meetings, etc. -Became a head server within 3 months & team leader within 6 months.

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 sequencers.-Restriction digest analysis.-Carried out upstream and downstream processing and bacterial cell culture.-Check inventory and replenish consumable sequencing supplies.-Prepare buffers and related solutions-Sequencing data analysis.-Work with LIMS program to track orders-Communicate with customers by phone and e-mail in a friendly & professional manner.-Application of techniques associated with purified PCR and plasmid handling, and RCA of bacterial and phage colonies.-Strictly follow SOPs in sample handling, project processing and documentation.-Process development and documentation.-Take steps to troubleshoot issues and effectively communicate the same to customers to resolve them.-Travel to other sites when needed.

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.