A wholly owned subsidiary of B. Layne LLC
●Sweat sensing technology detecting thyroid stimulating hormone (TSH) for real-time (RT) thyroid diagnostics optimizing daily dosing based on metabolic need catering to Hashimoto's and Hypothyroid patients
●Four Patent Filings – Patents Pending
●MIT-URI Ventures - Winter 2020 Cohort

•Quality Control, lead liaison to Facilities/Operations team for succinct pre-post calibration and validation schedules.
•Quality Control and Quality Assurance exception/legacy project documentation and reporting
•Follow applicable SOPs and policies upholding QMS integrity
•Technical writer of deviation, corrective action, change control reports according to LFB policies and procedures.
•Conduct technical investigations for compliance writing in collaboration with QC laboratory personnel and management.
•Work cross departmentally with QA and other groups to collaborate on and author quality system exceptions and documents and process improvements.
•Responsible for timely closure of new Quality System exceptions and longer-term remediation for legacy exceptions.
•Team participant for biannual review of SOPs,

Quality Systems Management lead
•Author of Product Stability Reports
•Quality Control regulatory support for EU and FDA analytical methodology updates for BLA submissions
•Quality Control, lead liaison to Facilities/Operations team for succinct pre-post calibration and validation schedules.
•Quality Control and Quality Assurance exception/legacy project documentation and reporting
•Follow applicable SOPs and policies upholding QMS integrity
•Technical writer of deviation, corrective action, change control reports according to LFB policies and procedures.
•Conduct technical investigations for compliance writing in collaboration with QC laboratory personnel and management.
•Work cross departmentally with QA and other groups to collaborate on and author quality system exceptions and documents and process improvements.
•Responsible for timely closure of new Quality System exceptions and longer-term remediation for legacy exceptions.
•Team participant for biannual review of SOPs,

QMS Support
•CAPA Change Control Deviations OOS investigations and closures

Document Control – Contract via Complete Staffing Solutions
●QMS Support and document and change control
●Technical writing
●QMS document site integration

Managed quality system of humanitarian project submissions, proposals and contracts for financial aid packages
●Edited and presented new financial and development projects to governmental ministries for socio economic well-being of populations through improved infrastructure, health, education, and fair trade practices
●Contract Management Sovereign Guarantee financial platforms for integration to Governmental Development Plans incorporating local sustainable efforts within the business plan
●Editor and Group Presenter: Comprehensive National Development proposal: Ministry of Tunisia. Presented 2014
●Editor and Group Presenter: Comprehensive National Development proposal: Ministry of Cameroon. Presented 2014
●Proposal Editor: Comprehensive National Development proposal: Ministry of Equatorial Guinea & Ghana 2014

Now a Perkin Elmer Company
●IQ/OQ/PQ-PV validation execution for varying laboratory equipment following client SOP's and infrastructure in cGLP/cGMP facilities.
●Specialty in customized protocols and specifications per equipment type meeting client's requirements
●Project Management to onsite engineering teams for laboratory validations
●SME to customized Validation protocols for laboratory validation master plans
●Identified gaps in client operator usage versus instrument limits, specification, and uncertainty
●Non-compliance reporting to clients for immediate initiation of OOS and CAPA within client system and internal LabMetrix QMS
●Trained new validation teams in IQ/OQ/PQ-PV execution across multiple laboratory instrumentation disciplines in cGLP and cGMP environments, under 21CFR1 1and 820-quality compliance with certified metrology ISO 17025-certification
●Global laboratory sales and validation engineer training during the sales integration of LabMetrix Technologies to Pe

Now a Sanofi-Genzyme Company
●Quality control analysis supporting micro-polymer small molecule phosphate and cholesterol binding ingestible therapy for Renagel and Cholestagel via HPLC, GC, UV/Vis, IR TLC, titrations, and physical appearance testing, for raw material, in-process, final product and stability dynamic analytical data, in a cGMP/cGLP, 21 CFR 11, compliant laboratory environment
●Maintained laboratory instrument calibrations and validations schedule: IQ/OQ/PQ-PV
●Quality control analysis; raw material, in process, finished product and stability studies
●Advancement of GC method validations and technology transfer
●Direct analytical support for regulatory submissions and regulatory review
●Initiated investigations for OOS and CAPA instances
●Document revisions and change control

Now a Bristol Myers Squibb Company
●With researcher Dr. Shuang Liu PhD, purification and lyophilization of cancer therapy small molecules
●Radio labeled small molecules for therapeutic and imaging agents in animal studies
●Research under cGLP environment
●Protocol advancement in liquid chromatography purifications for clinical trial prep and subsequent quality control environments
●Direct research and quality support for drug discovery and development

Optimization of ICP methods of standard addition for plant analysis and product release.
●CAPA brine contamination of analytical lab
●Laboratory environment was decontaminated of residual brine implementing entry procedures by need only to reduce excess brine contamination for accurate analysis