Manager, Quality Control

• May 2023 - Present

Laboratory Systems Administrator and Data Integrity Compliance Officer

• Jun 2020 - May 2022

Senior Scientist - Quality Control

• May 2017 - Jun 2020

As a Senior Scientist - Quality Control, Laboratory (May 2017 – current), I utilize various chromatography techniques and laboratory equipment to analyze raw material, in-process, finished products, stabilities and sampling. I am responsible for the Stability program and LC/GC Columns project, write SOP, training new analysts and perform quality reviews of Test Packages.

Quality Control Supervisor and Analyst - Laboratory Systems

• Aug 2011 - Sep 2016

As a Quality Control Supervisor (Jan 2014 – Sep 2016), I managed 19 employees performing sampling and analyses of raw material, finished products, and stabilities. I scheduled and prioritized workload distribution for API, raw materials, drug products, and ongoing and long-term stabilities and analyzed process and cleaning validations and sampling of API and raw materials. I represented the laboratory during audits and inspections and supported the QC Coordinator in preparing budgetary KPIs and coordinating CAPEX schedules. I managed deviation and investigation of out-of-specification results as well as edited and reviewed standard operating procedures (SOPs) and test specifications. Further, I oversaw the validation and release of API, raw materials, and drug products in SAP software as well as employee training for direct reports on equipment and processes and managed key performance indicators (KPIs) for Quality Control and performed lead time analyses. As an Analyst for Laboratory Systems (Jul 2011 – Dec 2013), I was requested by the QC Coordinator to assume supervisory responsibilities, fielded questions from other analysts, and scheduled analyses. I edited test specifications, risk analysis assessments, and SOPs and administered employee training registration and paperwork archives for 24 employees. Further, I managed deviations and supported audits by delivering necessary documents to the auditor and oversaw calibration and preventive maintenance of laboratory equipment. Show less

Quality Control Analyst

• Jan 2004 - Jul 2011

As a Senior Analyst for Quality Control - Laboratory (Mar 2010 – Jun 2011), I performed complex analyses and implemented analytical transfers.As a Mid-Level Analyst for Quality Control - Laboratory (Oct 2007 – Feb 2010), I utilized various chromatography techniques and laboratory equipment to analyze process and cleaning validations and determined stability of drug products (liquids, solids, aerosols) in long-term and in-process projects. I trained 10+ analysts in equipment procedures and utilized SAP to release API, raw materials, and drug products.Prior roles with Boehringer Ingelheim:• Junior Analyst – Quality Control, Laboratory (Jan 2005 – May 2006)• Trainee – Quality Control, Laboratory (Jan 2004 – Dec 2004) Show less

Quality Control and Product Development Supervisor

• Jul 2005 - Dec 2005