Rjay Arcaira

Documentation Specialist with experience managing controlled documents, SOPs, quality records, and compliance documentation in regulated environments. Proven ability to maintain document accuracy, support audit readiness, streamline review processes, and ensure adherence to quality management system requirements. Extensive experience in biotechnology; specializing in the design, validation, and implementation of FDA-compliant assays supporting drug development and quality standards.

Highly skilled in cross-functional collaboration with Quality Control (QC), Quality Assurance (QA), Research & Development (R&D), and manufacturing teams to ensure regulatory compliance and project delivery. Technical expertise includes utilizing the following software and systems: Veeva, Trackwise, Benchling, GraphPad, PRISM, and LIMS.

Quality Assurance Specialist at CSL Plasma (2025-10 – Present)

• Oversaw Quality Management System (QMS) activities for center operations, ensuring compliance with FDA and GHA regulations, CLIA/COLA requirements, and internal company policies through internal audits and documentation reviews.
• Audited the documentation records for 400+ weekly donations, investigating any inconsistencies or non-conformities that would affect records accuracy and operational regulatory readiness.
• Facilitated and monitored the training compliance of 20+ staff members on company SOP's and center practices daily and communicating with management of any SOP revisions that required updated training or materials
• Collaborated with the operations team to implement CAPAs and optimizing processes that led to the reduction of documentation errors by 10% and streamlining workflows that hindered overall productivity

Research Associate II at Tenaya Therapeutics (2021-08 – 2025-03)

• Spearheaded the design and optimization of 4 droplet digital PCR (ddPCR) assays for AAV9 gene expression, 2 ELISA assays for biomarker detection, and the development of a potency assay
• Authored 6 Standard Operating Procedures (SOPs) and 6 qualification reports that have been used for routine testing of two clinical AAV gene therapy programs.
• Led assay implementation initiatives by coordinating method development activities, troubleshooting technical challenges, and facilitating communication among cross-functional stakeholders.
• Partnered with Research & Development scientists to develop and improve potency assays supporting product characterization and advancement through development milestones.
• Proficient in method development using UV-Vis spectroscopy, fluorescence-based assays, and BCA-based protein quantification.
• Managed bi-weekly assay progress meetings, presenting updates and troubleshooting strategies to cross-functional teams, facilitating collaborative solutions and expediting experimental timelines
• Performed data analysis and trend evaluation for ddPCR and ELISA assays, providing scientific recommendations that supported project decisions and product advancement.
• Guided the implementation of Benchling Software across the lab, developing standardized templates, protocols, and inventory tracking tools that streamlined documentation and improved data accessibility

Quality Control Analyst at Genentech (2019-05 – 2020-10)

Performed routine and non-routine analytical testing on raw materials, in-process samples, and finished products in compliance with GMP, SOPs, and regulatory guidelines.

• Conducted routine bioburden and endotoxin testing on drug substances and drug products to ensure microbial safety and product sterility in compliance with industry standards.
• Performed TOC (Total Organic Carbon) testing to monitor and control organic contamination levels in water, materials, and products, ensuring adherence to quality specifications.
• Utilized spectrophotometry to measure protein concentrations and assess the quality of samples, ensuring accurate and reproducible results.
• Investigated and documented out-of-specification (OOS) and out-of-trend (OOT) results, collaborating with QA and manufacturing to support timely resolution.

Bachelor's in Integrative Biology – University of California, Berkeley (2017)