Enrique Abreu Takemura
Summary
Detail-oriented Quality Control professional with a Master’s degree in Molecular Biotechnology and over 5 years of combined experience in cGMP pharmaceutical and clinical laboratory environments. Proven track record in executing rigorous data verification, cross-functional audit readiness, and technical documentation management across enterprise laboratory systems (LIMS, SAP, NuGenesis). Adept at ensuring strict data integrity compliance (ALCOA+ standards), managing quality metrics, and reviewing complex datasets to support regulatory expectations and operational efficiency.
Overview
6
6
years of professional experience
Work History
Quality Control Analyst II
Partner Therapeutics
Lynnwood, WA
08.2021 - Current
- Perform comprehensive review and verification of large, technical datasets including laboratory test results, batch records, and quality metrics to ensure 100% compliance with cGMP regulations and internal SOPs.
- Manage, input, and audit critical data across multiple validated enterprise systems including LIMS, SAP, QAD, and NuGenesis, maintaining total data traceability and integrity.
- Validate laboratory documentation and technical records to support internal quality reviews, regulatory compliance, and audit readiness.
- Collaborate closely with cross-functional teams to resolve data discrepancies in real-time, streamlining data verification workflows while enforcing strict data confidentiality protocols.
Clinical Laboratory Technician
Adaptive Biotechnologies
Seattle, Washington
12.2020 - 08.2021
- Supported clinical operations by accurately managing, entering, and reviewing patient and study data to guarantee strict adherence to study protocols and regulatory standards.
- Maintained absolute data integrity and compliance by reviewing technical documentation required for high-stakes clinical trials.
- Enforced meticulous attention to detail and strict information confidentiality guidelines while handling complex clinical records.
- Contributed to internal process improvement initiatives to streamline data management workflows, boosting overall trial execution efficiency.
Education
Master of Science - Molecular Biotechnology
Interamerican University of Puerto Rico, Aguadilla
Puerto Rico07-2020
Bachelor of Science - Biology
University of Puerto Rico, Mayagüez Campus
Puerto Rico05-2018
Skills
- Data Integrity & Review: ALCOA principles, Audit Trail Review, Multi-system Data Verification
- Regulatory & Quality Systems: cGMP Compliance, USP/EP/JP Compendial Methods, OOS/OOT & Deviation Support
- Software & Lab Systems: LIMS, SAP, NuGenesis, QAD, Electronic Data Management Systems (EDMS)
- Technical Skills: Molecular Biotechnology, Wet Chemistry Data Review, Technical Documentation
Timeline
Quality Control Analyst II
Partner Therapeutics
08.2021 - Current
Clinical Laboratory Technician
Adaptive Biotechnologies
12.2020 - 08.2021
Master of Science - Molecular Biotechnology
Interamerican University of Puerto Rico, Aguadilla
Bachelor of Science - Biology
University of Puerto Rico, Mayagüez Campus