Experience

BIOHM Health

• United States
• Wellness and Fitness Services
• 1 - 100 Employee

• Vice President Operations

  • Nov 2021 - Present

  Business and product development for microbiome testing Sequencing lab and science pipeline project management Testing kit logistics and supply chain management

• Operations Manager

  • Jul 2020 - Nov 2021

  Cleveland, Ohio, United States Product design, development & launch Business development Ecommerce fulfillment management & development Project management Management and development of fulfillment team Inventory management Amazon FBA, FBM

• Logistics and Supply Chain Lead

  • Dec 2018 - Jul 2020

  Cleveland, OH Inventory management Manufacturing Lead Product development Logistics & fulfillment management Amazon FBA, FBM



VWR, part of Avantor

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Control Lead

  • Nov 2016 - Dec 2018

  Cleveland/Akron, Ohio Area Leads, coordinates and executes QC validation testing protocols for ISO 13485 and 21 CFR 820 compliant medical devices Arranges new hire training, coordinates cross-training activities and provides training and guidance to laboratory staff Performs technical review and approval of Quality Control laboratory records/LIMS for product disposition, reviews record for method or procedure adherence, calculations and usage of instrument(s)/equipment Schedules, prioritizes and/or… Show more Leads, coordinates and executes QC validation testing protocols for ISO 13485 and 21 CFR 820 compliant medical devices Arranges new hire training, coordinates cross-training activities and provides training and guidance to laboratory staff Performs technical review and approval of Quality Control laboratory records/LIMS for product disposition, reviews record for method or procedure adherence, calculations and usage of instrument(s)/equipment Schedules, prioritizes and/or coordinate urgent items in Quality Control; works in conjunction with QC Coordinators, Operations or Sales as needed Conducts and documents investigations for laboratory out of specification results, recommends acceptance or rejection of materials or products based on test results. Revises or edits Quality Control documents in the QMS system such as work instructions, training manuals, or QC protocols following current processes Lead HPLC technician responsible for 100% of HPLC testing for product release, works with senior scientists on method development and execution, responsible for documentation and management of HPLC equipment, reagents and standards Continues high volume chemistry and microbiological testing of raw materials, in-process formulations and final products to established specifications Executed and lead a week long EMPQ study to validate classification of new controlled areas for medical device manufacture

• Senior Quality Control Technician

  • Mar 2016 - Nov 2016

  Solon, OH Utilized and operated advanced instrumentation and techniques, examples include but not limited to: HPLC, PCR, Gel electrophoresis, Nuclease assays, ISE assay and Protein assays. Performed confirmatory testing for out of spec (OOS) investigations to determine product disposition Created and developed work requests for manufactured product adjustments Performed instrument calibrations, certain scheduled Preventative Maintenance (PM) and/ or minor repairs for instruments or… Show more Utilized and operated advanced instrumentation and techniques, examples include but not limited to: HPLC, PCR, Gel electrophoresis, Nuclease assays, ISE assay and Protein assays. Performed confirmatory testing for out of spec (OOS) investigations to determine product disposition Created and developed work requests for manufactured product adjustments Performed instrument calibrations, certain scheduled Preventative Maintenance (PM) and/ or minor repairs for instruments or equipment Continued high volume chemistry and microbiological testing of raw materials, in-process formulations and final products to established specifications Performed routine Environmental Monitoring of classified areas



AMRESCO LLC

• Biotechnology Research
• 1 - 100 Employee

• Quality Control Technician II

  • Sep 2014 - Mar 2016

  Solon OH Performed QC chemistry and microbiological analysis of raw materials, in-process formulations and final products for an ISO 13485 certified biochemical and Medical Device manufacturer Utilized laboratory equipment and instruments including but not limited to: UV/vis, FTIR, Metrohm Autotitrator, Karl Fischer, Milliflex, polarimeter, refractometer and gel electrophoresis Performed wet chemistry and analytical testing per USP, EP, JP, BP and ACS Compendia Entered final… Show more Performed QC chemistry and microbiological analysis of raw materials, in-process formulations and final products for an ISO 13485 certified biochemical and Medical Device manufacturer Utilized laboratory equipment and instruments including but not limited to: UV/vis, FTIR, Metrohm Autotitrator, Karl Fischer, Milliflex, polarimeter, refractometer and gel electrophoresis Performed wet chemistry and analytical testing per USP, EP, JP, BP and ACS Compendia Entered final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) Performed EMPQ and routine Environmental Monitoring of ISO 7 and ISO 8 clean rooms Show less



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Microbiologist / Environmental Monitoring

  • Jan 2014 - Jul 2014

  Bedford, OH Provided Quality Control Microbiology support for a cGMP compliant liposomal chemotherapy compounding operation Read samples for microorganism growth, characterized microorganisms though isolation and subculturing to asses risk and analyze conformance Conducted laboratory investigations and risk assessments resulting in root cause analysis Conducted viable aerobic sampling of controlled cytotoxic/genotoxic production areas and WFI system for detection of microbial… Show more Provided Quality Control Microbiology support for a cGMP compliant liposomal chemotherapy compounding operation Read samples for microorganism growth, characterized microorganisms though isolation and subculturing to asses risk and analyze conformance Conducted laboratory investigations and risk assessments resulting in root cause analysis Conducted viable aerobic sampling of controlled cytotoxic/genotoxic production areas and WFI system for detection of microbial growth Reviewed raw data, lab notebooks and electronic data for completeness, compliance and accuracy Effectively communicated and coordinated complex monitoring routines with operations, QA and management at daily shift-exchange meetings Selected for additional site decommissioning activities including document review, investigation and data archival Show less



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Environmental Monitoring Technician

  • Sep 2010 - Dec 2013

  Bedford, OH Employed as a Microbiology technician for a large cGMP accredited sterile injectable pharmaceutical manufacturing facility. Subject Matter Expert for environmental monitoring of aseptic filling operations. Continuously trained and maintained compliance with internal SOPs, Federal, and International rules and regulations. Identified gaps in procedure and implemented process improvement to departmental Standard Operating Procedures Personally accountable for… Show more Employed as a Microbiology technician for a large cGMP accredited sterile injectable pharmaceutical manufacturing facility. Subject Matter Expert for environmental monitoring of aseptic filling operations. Continuously trained and maintained compliance with internal SOPs, Federal, and International rules and regulations. Identified gaps in procedure and implemented process improvement to departmental Standard Operating Procedures Personally accountable for collection, documentation, review, and time-critical delivery of over 22,000 microbiological samples per year. Performed and trained technicians on viable surface (RODAC, swab, CDC), viable air, non-viable particulate (NVP) and water/WFI sampling (Bioburden, LAL, HIAC). Led and organized environmental monitoring teams in nine (9) facility start-up Environmental Monitoring Performance Qualification studies (PQ/EMPQ). Attained and upheld 20+ Media Fill Qualifications as an accredited Aseptic Operator directly trusted with critical sampling of aseptic processes required for product batch release. Performed technical writing for validation protocols, standard operating procedures, controlled lists, risk assessments, and investigations. Organized aggregated and reviewed environmental monitoring data for completeness in software suites MODA-EM, MIMS and Microsoft excel. Performed IQ/OQ validation of monitoring equipment. Show less