Devin Poor
Chicago,IL
Summary
Experienced Quality Specialist with a background in implementing and monitoring quality control systems. Strengths include strong analytical skills, keen eye for inconsistencies, and ability to troubleshoot complex processes. Notable impact on previous work includes improving streamlining operations and reducing costs through effective quality assurance initiatives. Known for fostering adherence to regulatory standards and promoting continuous improvement culture within teams.
Overview
11
11
years of professional experience
Work History
GMP Operational Quality Specialist
VERTEX PHARMACEUTICALS
Boston, MA
11.2022 - 11.2024
- Delivered QA Analytical support for release and stability programs.
- Conducts quality assurance reviews of GMP data supporting product release and stability.
- Coordinates with internal and external business partners to address quality issues.
- Facilitated assessments of product impact while analyzing root causes for OOS/OOT investigations.
QC Analyst III
ALNYLAM PHARMACEUTICALS
Cambridge, MA
02.2016 - 09.2022
- Oversaw outsourced cGMP stability programs to support Quality Control.
- Facilitates submissions by contributing to analysis and stability documentation.
- Monitored trends in stability data provided by CTLs and suggested initiating OOTs as needed.
- Reviewed Quality Events initiated by CTLs.
- Analyzed retest data for significant PRM/WRS, created updated COAs and supplied to CTLs.
- Implemented comprehensive LIMs stability module.
QC Analyst II
ALNYLAM PHARMACEUTICALS
Cambridge, MA
01.2016 - 09.2022
- Aided in Quality Control initiatives, emphasizing microbiology and raw materials.
- Operated analytical instrumentation for consistent assay performance.
- Generate and review analytical data for releasing bulk drug products.
- Developed and validated an In Vitro Release assay.
- Developed and implemented LIMs system for EM module.
QC Technician
GENZYME INC.
Framingham, MA
06.2013 - 01.2016
- Collected Environmental Monitoring and Critical Utility samples from controlled laboratory areas.
- Collaborated across multiple lab units for efficient specimen management and test processing.
- Conducted data entry in LIMS with exceptional precision.
- Ensure GMP compliance
- Certified in sterile filling processes.
- Led daily operations as Critical Utility Bench Lead.
- Trained staff on gowning entry protocols.
- Coordinated validation studies.
Education
Bachelor of Science Degree - Biology, Chemistry minor
FITCHBURG STATE UNIVERSITY
Fitchburg, MA07.2010
Skills
- Validation Studies
- Knowledge of GMPs
- Data Trending
- Report Authorship
- SOP Revision
- Managing and Writing Exceptions
- Specimen and Tissue Handling
- Aseptic Technique
- Implementation of KPIs
- Contamination Control
- Quality Vendor Oversight
- Management
Timeline
GMP Operational Quality Specialist
VERTEX PHARMACEUTICALS
11.2022 - 11.2024
QC Analyst III
ALNYLAM PHARMACEUTICALS
02.2016 - 09.2022
QC Analyst II
ALNYLAM PHARMACEUTICALS
01.2016 - 09.2022
QC Technician
GENZYME INC.
06.2013 - 01.2016
Bachelor of Science Degree - Biology, Chemistry minor
FITCHBURG STATE UNIVERSITY
Similar Profiles
Chavannes ValbruneChavannes Valbrune
Manufacturing Associate at Vertex PharmaceuticalsManufacturing Associate at Vertex Pharmaceuticals
Laurent CUILLERLaurent CUILLER
Key Account Manager - Maladie Rare Mucoviscidose at VERTEX PharmaceuticalsKey Account Manager - Maladie Rare Mucoviscidose at VERTEX Pharmaceuticals
Corina PoseyCorina Posey
Associate Director Global Quality Systems-Compliance at Vertex PharmaceuticalsAssociate Director Global Quality Systems-Compliance at Vertex Pharmaceuticals
ALVIN BREWSTERALVIN BREWSTER
Business Engagement & Technology Principal Analyst at Vertex PharmaceuticalsBusiness Engagement & Technology Principal Analyst at Vertex Pharmaceuticals
Amra HuskicAmra Huskic
Market Leader – Chicagoland Region at Help at HomeMarket Leader – Chicagoland Region at Help at Home