Brian Calderon

Covina

Summary

Detail-oriented life sciences professional with experience supporting highly regulated, SOP-driven environments within FDA-compliant organizations. Strong background in Good Documentation Practices (GDP), protocol adherence, and cross-functional collaboration. Seeking to contribute to Clinical Operations by supporting clinical trial documentation, compliance activities, and study coordination in a Clinical Trials Associate role.

Overview

years of professional experience

Certification

Work History

Biomanufacturing Technician II

Grifols Biological Sciences

Los Angeles

09.2023 - 01.2026

Maintained, reviewed, and tracked GMP/GDP documentation in accordance with SOPs, supporting audit readiness, document reconciliation, and regulatory compliance in FDA-regulated environments.
Followed strict protocols and procedures to ensure documentation accuracy, completeness, and traceability across operational workflows.
Supported controlled documentation processes by completing logs, forms, and reports with a high level of accuracy and consistency.
Collaborated cross-functionally to resolve documentation discrepancies and ensure timely completion of required records.
Utilized electronic systems to retrieve, record, and maintain operational and compliance-related documentation.
Supported inspection and audit readiness by ensuring documentation was properly maintained, organized, and readily accessible.
Maintained confidentiality and compliance with corporate, regulatory, and safety requirements at all times.

Biomanufacturing Technician I

Gilead Sciences

San Dimas

06.2022 - 08.2023

Completed detailed GMP/GDP documentation in alignment with SOPs and regulatory requirements, supporting audit and inspection preparedness.
Supported documentation control processes within a highly regulated environment, ensuring accuracy, completeness, and compliance.
Adhered to FDA-regulated procedures and documentation standards while executing assigned operational tasks.
Maintained organized records and logs to support quality reviews, compliance activities, and internal audits.
Collaborated with cross-functional teams in a process-driven environment to meet quality, safety, and compliance objectives.
Utilized electronic and manual documentation systems to track and maintain required records in accordance with established procedures.

Education

Bachelor of Science - Biology

Louisiana State University

Baton Rouge, LA

05-2024

Associate of Science - Biotechnology

Citrus College

Glendora, CA

06-2022

Skills

Good Documentation Practices (GDP / GDocP)
SOP and protocol-driven environments
FDA-regulated operations
Clinical documentation review, tracking, and reconciliation
Audit and inspection readiness

Document organization, filing, and archival support
Cross-functional collaboration and communication
Electronic documentation and data tracking systems
MS Word, Excel, PowerPoint, Outlook, Adobe
Strong attention to detail, time management, and organizational skills