Hardworking and passionate candidate with strong organizational skills eager to secure quality compliance position. Ready to help the team achieve regulatory compliance requirements.
Overview
5
5
years of professional experience
Work History
Lead Quality Investigator
Takeda Pharmaceuticals
08.2022 - Current
Conducts and writes-up deviations investigations in a pharmaceutical facility.
Responsible for the resolution of deviations, CAPAs, or other documents in order to meet production and product release requirements.
Supports production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
Reviews and releases batch records and associated documents against Standard Operating procedures and internal guidelines as assigned.
Administer and maintain relevant databases, prepare and issue reports as defined by the area.
Performs internal self-inspections and external audits by collecting and reviewing documents as assigned by management.
Data Analyst
Perkin Elmer
11.2020 - 05.2022
Analyzed clinical test results for SARS-CoV-2 according to standard operating procedures.
Participated in changes and improvements to protocol and execution.
Maintained good record keeping for all testing performed as mandated by established protocols.
Assisted with troubleshooting skills and be able to identify problems that may adversely affect test performance or reporting of test results.
Participated in staff meetings to evaluate current trends, discuss issues, and plan for future steps.
Research Scientist Intern
UCI, Blumberg Molecular Laboratory
06.2018 - 06.2020
Studied a family of regulatory proteins called nuclear hormone receptors and their ligands
Performed cell culture, blotting, gel electrophoresis, chromatography, flow cytometry, etc.
Processed, organized, analyzed and summarized data, reporting experiment results using a variety of scientific applications
Education
Bachelor of Science - Biology
University of California, Irvine
Irvine, CA
Associate of Science - Health Sciences
Glendale Community College
Glendale, CA
Skills
P>Auditing experience
P>Data presentation skills
P>Trackwise use
P>Quality management
P>Understanding of regulatory frameworks
Timeline
Lead Quality Investigator
Takeda Pharmaceuticals
08.2022 - Current
Data Analyst
Perkin Elmer
11.2020 - 05.2022
Research Scientist Intern
UCI, Blumberg Molecular Laboratory
06.2018 - 06.2020
Bachelor of Science - Biology
University of California, Irvine
Associate of Science - Health Sciences
Glendale Community College
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