Looking for a job

Arlette Flores

@arletteflores

I build inspection-ready pharmaceutical quality systems, validation programs, and regulatory submissions that support cGMP compliance.

United States

Message

What I'm looking for

I'm looking to lead and strengthen pharmaceutical quality systems, validation, and regulatory compliance programs, with opportunities to improve inspection readiness, build scalable processes, and partner cross-functionally on cGMP operations.

At Xseer Pharmaceuticals, I led California Board of Pharmacy pre-inspection submissions that resulted in successful 503B licensure. I manage change controls, deviations, CAPAs, validation protocols, batch disposition support, and inspection-readiness activities across site quality systems.

I've built eQMS infrastructure and governing SOPs for deviations, CAPAs, change controls, OOS investigations, supplier qualification, and document control. I also serve as a quality systems and regulatory compliance SME, guiding risk assessments, labeling reviews, GxP gap analyses, metrics, and cross-functional training.

Previously at TORL Bio and ImmunityBio, I established cGMP compliance frameworks, administered Veeva Vault, supported validated system implementations, and improved labeling, raw-material disposition, supplier, ERP, and inspection processes. I hold an M.S. in Regulatory Affairs and bring hands-on experience with FDA guidance, 21 CFR 210/211, USP <1790>, and 503B regulations.

Experience

Work history, roles, and key accomplishments

Current

QA Project Specialist II

Current

Xseer Pharmaceuticals

Oct 2025 - Present (11 months)

Directed regulatory pre-inspection submission strategy for California Board of Pharmacy, achieving successful 503B licensure. Authored and executed validation protocols, managed change controls and deviations, and built eQMS infrastructure.

GMP IQ OQ PQ Validation Validation Protocols Change Control Deviation Management CAPA EQMS Regulatory Submissions USP 1790 FDA Guidance Documents Batch Record Review Label Review Quality Metrics Training

QA Associate

TORL Bio

Aug 2024 - Oct 2025 (1 year 2 months)

Established SOPs and compliance frameworks, introduced deviations management and change control processes, and served as Veeva Vault system owner supporting validation and document control.

SOP Development Deviation Management Change Control Root Cause Analysis CAPA Veeva Vault Systems Validation UAT Document Control EQMS

Senior QA Associate

ImmunityBio

Mar 2022 - Aug 2024 (2 years 5 months)

Assisted in initiating commercial label artwork review for an FDA-approved BLA, supported raw material disposition and ERP implementation, and authored regulatory documentation. Conducted inspections and developed quality metrics.