QC-RP Manager

• Jan 2020 - Present

• Manage and develop professional and technical skills and performance of QC-RP department • Organize workflow within the department to optimize human and equipment resources• Determine and implement plans to meet equipment and manpower needs• Maintain compliance with GMP and ISO testing requirements in the QC-RP laboratory• Interact with Management and other departments (Production, QA, Sales) to meet corporate goals• Work with senior technical staff to develop and incorporate state-of-the-art analytical methods to improve precision and reduce testing time• Ensure quality and timely completion of sample analyses Show less

Assistant GMP QC Group Leader

• Apr 2015 - Jan 2020

• Manage IT efforts in the laboratory• Manage validation and qualification activities• Responsible for working with vendors on service contract agreements and renewals and coordinating annual PM/OQ service visits• Responsible for the maintenance and continual improvement of the laboratory electronic data systems• Coordinate laboratory activities and training for a staff of around 8 chemists• Participate in GMP documentation activities including deviations, change controls, CAPAs, OOS investigations, instrument qualifications, validation/verification protocols, annual trend reports (specifically OOS investigations and environmental monitoring), and biennial review of GMP software (OpenLab CDS and Biovia LES/LIMS)• Participate in FDA, customer, and internal audits• Perform quality review for release of raw materials and finished products• Author and update SOPs, Test Methods, and Protocols• Perform training within the department (analytical techniques, refresher training) and across departments (Biovia LES/LIMS)• Actively pursue opportunities for continued learning through attendance at the annual Biovia user conference and Agilent seminars Show less

Senior QC Chemist

• Jan 2015 - Apr 2015

QC Chemist

• Oct 2008 - Jan 2015

• Performed analyses on both GMP and non-GMP products using GC/MS, QNMR, 1H NMR, 13C NMR, HPLC, TOC, FTIR, Karl Fischer Titration, and other wet chemistry techniques• Led the efforts for the installation and validation of the Biovia LES/LIMS electronic data system• Performed qualifications for the Biovia LES/LIMS system• Developed methods for GC/MS, NMR, TOC, and Polarimeter• Performed test method validations and qualifications• Performed annual instrument qualifications for GC/MS• Maintained analytical instruments including GC/MS, TOC, Polarimeter, and Karl Fischer titrator• Authored and updated SOPs, Test Methods, and Protocols Show less