Kyle Stoddard
Associate Director, Quality Assurance
- Role
- Associate Director, Qa for Qc Compliance and Investigations Team at Genetix Biotherapeutics
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director, Qa for Qc Compliance and Investigations Team
Sep 2024 — Present · Somerville, MA, US
Manage and Lead QC Compliance (QA for QC) Team responsible for QA Oversight and Support of Genetix/bluebird bio QC Testing supporting all clinical and commercial cell banks, plasmid, LVV, and Drug Products. QA Support of Method Lifecycle Management. Coordinate and Drive Quality Oversight Plan (QOP) for CTO and Draft and Revise bluebird bio/Genetix CTO quality agreements. QA Support of all QC owned QMS. Drive improvements to Lab Investigation (OOS, OOT, QC Trends, etc) process, procedure, communication and management. Routinely present metrics to QLT. Support DP Manufacturing Capacity Increase to exceed Genetix patient delivery goals for 2025.
Education
Bridgewater State College
Bachelor of Science - BS, Chemistry and Biology
Skills
- Analytical Method Validation
- Sop Development
- Lims
- Analytical Chemistry
- Validation
- Mass Spectrometry
- Trackwise
- Change Control
- Method Transfer
- Biopharmaceuticals
- Laboratory Automation
- Technical Writing
- 21 Cfr Part 11
- Corrective and Preventive Action (Capa)
- Technology Transfer
- Glp
- Lean Six Sigma
- Deviations
- Capa
- Quality System
- Quality Systems
- Project Management
- Computer System Validation
- Laboratory Information Management System (Lims)
- Hplc
- Lc-Ms
- Chromatography
- Instrument Validation
- Biotechnology
- Equipment Qualification
- Quality Auditing
- Aseptic Processing
- Quality Control
- Gmp
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