Caleb Green
Quality Control Analyst at Biogen
- Role
- Quality Control Microbiology Associate Ii at Biogen
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Caleb Green
Emerging healthcare professional with experience in data analysis and patient care. Known…
Experience
Quality Control Microbiology Associate Ii
May 2024 — Present · Morrisville, NC, US
Trained in a wide range of microbiological assays, including: Endotoxin Testing, Container Closure Integrity Testing, Biological Indicator Testing, Spore Titer Testing, Sterility Testing, Gram Staining, Subculturing, and Microbial Identification (MALDI)-Serves as SmartQC lead, overseeing timely execution of product testing, tracking sample progress, and providing daily updates to ensure alignment with deadlines and quality standards-Presents Micro ID updates in Environmental Review Board meetings, documenting meeting minutes and routing records through MyCIMS/Veeva for compliance and transparency-Developed and optimized the Micro ID workflow to reduce turnaround time and improve efficiency in LIMS data entry; manages shipping schedules for priority and non-priority samples and provides senior management with real-time updates on testing status-Partnered with cross-functional LIMS teams to build new ELNs and revise fields in existing test methods, streamlining routine testing-Supports quality investigations by collaborating with QA on minor/major deviations, aborted/invalid assays, and initiating and implementing planned exceptions in Trackwise-Leads CAPA initiatives by revising SOPs, authoring work instructions, and driving process improvements to prevent recurrence-Completed train-the-trainer program and actively trains team members across multiple assays.
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