EMILY ATILANO
Thousand Oaks
Summary
Quality Complaints Senior Associate with 3+ years supporting technical investigations, device failure analysis, and combination product quality across Amgen’s portfolio. SME in PFS and lyo kit inspections, return unit assessments, and device disassembly workflows. Experienced in cross-functional collaboration with Forensics, Process Development, and Quality Engineering. Strong technical writer with experience supporting trending and investigation documentation. Currently completing an MBA + M.S. Biotechnology.
Overview
5
5
years of professional experience
Work History
Quality Complaints Senior Associate II
Amgen
07.2023 - Current
- SME for PFS and lyophilized (lyo) kit inspections, performing daily evaluations across Amgen’s commercial portfolio to support failure mode identification and technical investigations.
- Conduct quality records such as Return Unit Inspections (RUI) for combination products; generate detailed visual, mechanical, and analytical assessments used in early root cause analysis.
- Authored and implemented the Annie ConfiPen RUI SOP in Veeva; led team training and served as SME for complaint workflows and device disassembly (SureClick).
- Collaborate with Forensics, Process Development, Product Teams, and Quality Engineering to analyze device behavior, identify trends, and support investigation scoping.
- Support investigations by compiling evidence packages, performing data trending, and reviewing supporting documents to ensure alignment with quality system requirements.
- Perform brand security assessments, counterfeit detection, and product authentication testing.
- Mentor new hires on GMP documentation, complaint handling, device inspection workflows, and investigation expectations.
Laboratory Technician
Gather Labs
05.2022 - 08.2022
- Executed CLIA-regulated RNA extraction and PCR analysis with focus on accuracy, contamination control, and method reliability.
- Investigated unexpected test outcomes by reviewing reagent performance, equipment behavior, and workflow variations, contributing to root cause identification and process improvement.
- Conducted instrumentation performance evaluations and developed comparison reports supporting decisions on method capability and optimization.
- Assisted with refining test methods to increase consistency and reduce variability in diagnostic workflows.
- Maintained detailed lab documentation supporting audit readiness and data integrity requirements.
RNA Extraction Technologist
PerkinElmer
10.2020 - 05.2022
- Operated high-throughput automated diagnostic platforms (JANUS, Chemagic 360) ensuring equipment met reliability, performance, and quality requirements for SARS-CoV-2 testing.
- Troubleshot workflow deviations and equipment errors by reviewing run logs, reagent issues, and mechanical system performance, contributing to technical investigations.
- Performed routine calibration, verification runs, and preventative maintenance aligned with test method requirements.
- Identified workflow bottlenecks and contributed recommendations that improved throughput and reduced re-run rates.
- Maintained GMP-style documentation for sample handling, deviations, and investigation notes, supporting data integrity and compliance.
Education
M.S. Biotechnology + MBA (Dual Degree) -
CSU Channel Islands
05.2026
B.S. - Biology
California State Polytechnic University, Pomona
01.2020
Skills
- Veeva Quality Systems
- PFS & Lyo Kit Inspection and device handling
- Bioconnect
- FAST Analysis
- SureClick Disassembly
- X-Quick X-Ray
- Excel
- GMP Documentation
- Training and mentoring
- Team leadership
- Team supervision
- Complaint management
- Process improvement
Timeline
Quality Complaints Senior Associate II
Amgen
07.2023 - Current
Laboratory Technician
Gather Labs
05.2022 - 08.2022
RNA Extraction Technologist
PerkinElmer
10.2020 - 05.2022
B.S. - Biology
California State Polytechnic University, Pomona
M.S. Biotechnology + MBA (Dual Degree) -
CSU Channel Islands