• Serve as Subject Matter Expert (SME) for company’s Supplier Quality System.• Collaborate with cross-functional teams from customer service, regulatory, marketing, R&D, and operations to achieve projectand manufacturing success.• Evaluated and onboarded 18+ suppliers to meet operational needs, functioning as the first Point-of-Contact for vendors.• Conducted 10+ on-site and virtual audits as lead auditor to ensure supplier compliance.• Rebuild Supplier Quality System from the ground-up to reduce complexity, aligning with company’s annual critical initiatives and ISO 13485 compliance.• Perform root cause analysis on Potential Issue Reports (PIRs) and assess CAPA initiation.• Investigate Customer Complaints of finished goods and evaluate final disposition.• Present metrics to C-suite and executive team in quarterly management reviews.• Review weekly environmental monitoring reports via DicksonOne.• Manage Return Material Authorizations (RMAs) by performing quality assessment and evaluating finished product disposition.• Support all types of audits: internal, external, FDA, customer audits.• Facilitate Engineering Change Requests (ECRs) and host weekly ECR Review Board meeting.• Oversee design control of new product labels.• Support development and rollout of electronic ERP (QAD) and QMS (ETQ Reliance) systems.

• Ensure cGMP compliance for 503B compounding pharmacy operations of generic liquid drug injectables.• Regulatory Compliance: Title 21 of the CFR Part 11, Part 210 & 211, Part 820; ISO 9001:2015• Qualify critical vendors and establish quality agreements.• Manage SOP and document revisions via QT9 QMS Software and Microsoft SharePoint• Write and execute deviations, corrective & preventive actions (CAPAs) , change controls, qualityassessments, and risk assessments.• Support internal, external, customer, and vendor audits.• Review batch manufacturing records (BMRs) for release.• Quarantine and Release active pharmaceutical ingredient (API) and primary packaging materialsfor use.• Coordinate employee training of SOPs & test methods and maintain training matrix.• Secure and reconcile DEA Schedule III Controlled Substances.• Design and approve US Pharmacopeia (USP) drug labels for finished product.• Surveil environmental monitoring via Lighthouse airborne particle counters.• Collect pre-compounding WFI and 100% bulk samples from clean room for QC testing.• Perform secondary visual inspection as per acceptable quality limit (AQL) sampling.

Evaluated the efficacy of designed antimicrobial peptides (dAMPs) against lab and clinical strains of Mycobacterium abscessus

• Assisted local family physicians to address community healthcare goals. • Managed psychiatric clinic scheduling, virtual consults, and patient outcome reports on EMR system.

• Organize successful student events on campus to promote physical, nutritional, and sexual health.• Be a resource for students to enquire about health initiatives and services on campus.