Experience

Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Production Supervisor

  • May 2019 - Present

  •Serves as the department supervisor and project manager responsible for coordinating the day to day activities and tasks for 15-20 staff members •Provide Direct guidance to employees to ensure products and operations meet the company Quality System, cGMPs, and safety standards •Schedule resources, delegate work, and track progress of employees to ensure that all daily tasks are completed, filling in manufacturing responsibility gaps as necessary •Initiate, author, and perform departmental review of quality system records and documentation (i.e. SOPs, batch records, investigations, change control) Show less



RJ Lee Group

• United States
• Environmental Services
• 100 - 200 Employee

• Supervisor

  • Mar 2018 - May 2019

  Biotechnology & Pharmaceutical Services/Powder Metals Division•Served as the department supervisor and project manager responsible for coordinating the day to day activities and tasks for 10-20 staff members across multiple departments •Served as the primary project lead on FPM investigations related to contamination identification, root cause analysis, source determination, surface defect analysis, particle morphology evaluation, and particle size analysis•Managed regulatory test procedures and protocols linked to CAPA, OOS, and content uniformity investigations associated with the Biopharmaceutical industry•Drafted customized proposals and quotes for clients that are crafted specifically to their individual project needs using innovative analytical techniques and approaches Show less

• Scientist

  • Oct 2014 - Mar 2018

  •Performed sample preparation and analysis in compliance with standard operating procedures (SOPs) for a cGMP lab environment•Specialized in investigations utilizing Raman, HIAC, SEM-EDS, PLM, FTIR, and CCSEM•Developed training courses, reference materials, and presentations •Reviewed and revised Standard Operating Procedures. Reviewed and revised technical reports•Investigated and rectified QA/QC issues, instrument malfunctions, and matrix problems

• Lab Technician

  • Dec 2012 - Sep 2014

  •Sample preparation of powdered metals•Analysis of samples using Scanning Electron Microscopy•Project coordination, data tabulation, record keeping, and tracking of customer samples