Dana Trisha D. Garcia
Moorpark,CA
Summary
Dynamic Quality professional with a strong focus on cross-functional collaboration and analytical testing. Proven track record in leading compliance initiatives and driving process improvements.
Overview
10
10
years of professional experience
Work History
Senior Associate Quality Assurance II
Amgen
Thousand Oaks, CA
04.2022 - Current
- Coordinated cross-functional discussions to assess compliance and product quality impact risks
- Collaborated in the Micro Transformation Project (MTP) and accelerated software developments for improved batch record training processes
- Facilitated process improvement initiatives by digitalizing report review workflows, thus streamlining review processes
- Supported regulatory compliance by maintaining accurate documentation and records management for batch records and deviations
- Delivered real-time support for New Product Introductions (NPIs) and Process Performance Qualifications (PPQs) in DS Manufacturing
- Participated in plant audits and inspections
Senior Associate Quality Control
Amgen
Thousand Oaks, California
02.2016 - 04.2022
- Orchestrated scheduling, testing, and approvals to facilitate on-time completion of validation and transfers in collaboration with QC, AS and GMIT.
- Performed analytical testing for purity and general assays to support DS, DP, in-process and stability samples
- Engaged with the global Technical Excellence Team and Chromatography Task Force to evaluate method and equipment challenges aimed at driving process consistencies
- Facilitated change control activities for method revisions
- Collaborated in the introduction and validation of new laboratory equipment, expanding operational capabilities
- Streamlined cross-functional processes to minimize waste and rework, contributing to overall quality control efficiency
Education
Bachelor of Science - Biology
California State University, Channel Islands
Camarillo, CA12-2015
Master of Science - Biotechnology
California State University, Channel Islands
Camarillo, CA03-2026
MBA -
California State University, Channel Islands
Camarillo, CA03-2026
Skills
- Good Manufacturing Practices and Good Documentation Practices
- Audits and inspection readiness
- Skilled in High Performance Liquid Chromatography, Capillary Electrophoresis, Protein Concentration and Subvisible Particle Analysis by Light Obscuration
- Knowledgeable in Drug Substance processes including Cell Culture and Purification
- Proficient in Microsoft Office, Veeva and Trackwise, Empower, Pas X, LIMS, CIMS, CEMS, Maximo and Pi Vision
- Cross-functional collaboration
- Team leadership; training and mentoring
Accomplishments
Phi Theta Kappa Honor Society
Languages
English
Native/ Bilingual
Filipino
Native/ Bilingual
Timeline
Senior Associate Quality Assurance II
Amgen
04.2022 - Current
Senior Associate Quality Control
Amgen
02.2016 - 04.2022
Bachelor of Science - Biology
California State University, Channel Islands
Master of Science - Biotechnology
California State University, Channel Islands
MBA -
California State University, Channel Islands