• Implements, manages, and audits the company’s 5S program in over 140+ areas across 7 buildings.• Works with Manufacturing Management to define problems, perform root cause analysis, implement effective change plans & KPIs, and track cost savings.• Successfully planned and led multiple Kaizens by following PDCA and DMAIC cycle methodology.• Coaches quality and manufacturing groups on applying lean methodology to processes including Just-In-Time, Takt Time, Kanban, OPLs, Value-Stream.• Member of the Operations Senior Leadership Team serving as project manager for global continuous improvement projects and initiatives.• Expert in data management in Excel, Access, ERP systems, and MS SharePoint. Well-versed in Visual Basic and advanced MS Office/Sharepoint applications including workflow automation, InfoPath, Javascript, and Powershell.• Assisted QA in establishing a new Training Sharepoint, creating action plans from internal audit findings, and with reviewing and approving CAPA, NCMRs, and deviations.

• Managed 16 members of the testing and evaluation team within Quality Control for all immunoassay-based testing. Provided oversight on test scheduling based on constantly changing priorities. Addressed equipment maintenance, training, and employee needs on a daily basis. • As manager, was directly responsible for hiring, employee performance evaluation, and immediately addressing staff performance issues. Also served as an active coach and mentor to multiple first-time managers; created clear career paths and growth opportunities for all employees to succeed.• Tracked quality metrics and key performance indicators to ensure compliance to ISO 9001:2008 and then 9001:2015. Identified and executed multiple process improvement opportunities and leading to cost-savings in QC including the transition to a 4x10 scheduling format to keep up with test demands.• Served as QC representative in multiple cross-functional forums including GEMBA walks, Document/Configuration change boards, Material Review Boards, and as an approver for CAPA, NCMRs, and deviations.• Managed multiple QC improvement projects including developing the previously defunct product stability initiative into a successful program. Other improvements include consolidating documentation, initiating validation efforts for testing, and proposing/implementing QC test method improvements for our immunoassay products.• Highly experienced in using root-cause analysis in investigating NCMRs, deviations, and CAPAs. • Facilitated the validation and design transfer of new V-PLEX® and U-PLEX® products between R&D and Quality Control. Assisted in the QC design and transfer planning for PCR-based product testing.• Part of the design team for a QC test scheduling system with a specific role of defining the metrics and KPIs reported to upper management. Wrote countless design plans, test plans for customer contracts, department SOPs, and validation test methods & templates.

• Managed a team of 7 employees and their supervisors who supported immunoassay product testing and evaluation within Quality Control. • As manager, was directly responsible for hiring, employee performance evaluation, and immediately addressing staff performance issues.• Supervised product sustainment of all research grade catalog and custom items. Provided solutions for any issues and failures during functional product testing within the Quality Control group.• Created and updated multiple Sharepoint-based websites for QC test issue tracking, Certification of Analysis and Conformance, and QC reagent tracking. • Managed updates to the certificate of analysis creation procedure including engineering a new process and site. Contributed in a cross-functional collaboration with the website design team to integrate SharePoint with the MSD public domain site. Successfully transferred the ownership and site management to Quality Assurance.• Received two spot awards: for creating an interactive Quality Control reagent tracking log on SharePoint and for independently planning and managing the relocation of the entire Quality Control department to the new manufacturing facility in Rockville, MD.

• Supervised product sustainment of all released catalog items within the Phosphoprotein/Intracellular Signaling product line. Lead investigator for all issues that arose during functional product testing within the Quality Control group.• Redesigned, restructured and consolidated data analysis templates and test records used by members of the Quality Control group who tested and provided a disposition for products. Effort reduced number of immunoassay testing templates by 99%.• Updated error coding system to be consistent with GLP/GMP error documentation requirements.

- Designed, developed and released new and updated products for MSD's single and multiplex immunoassay format with a primary focus on intracellular/phosphoprotein targets. Became lead developer of all intracellular/phosphoprotein-related Early Access products and pharmaceutical-contracted projects.- Assisted in the troubleshooting of development-related issues with current catalog products.- Highly experienced in experimental design for assay development, qualification, optimization. Also experienced in 4-PL fit analysis/interpretation.- Restructured and organized electronic documentation, data analysis tools and inventory trackers for the entire R&D department which reinforced traceability amongst all cross-functional research groups.

• Created and revised SOPs and Work Instructions in preparing for CDC Form 1 accreditation of new worksite.

• Contributed as a technical lead in various client and government funded BSL-2/3 laboratory research projects. • Participated in the development, reagent qualification, and execution of multiple select agent assays. Trained in aseptic techniques, cell culture (MEF, Vero, Jurkat, HeLa), ELISA, and electrophoresis testing.• Proficient understanding of GLP (21 CFR 58) and ISO 9001. Created a GLP-compliant qualification system (IQ/OQ/PQ) for equipment. Authored and revised various GLP-compliant SOPs, methods, test records.• Experienced in the preparation, qualification, and optimization of experimental standards in immunoassays.

• Participated in various animal toxicological studies for Battelle’s pathology department.• Played a leading role in BSL-2 based studies completed under GLP at the Battelle Biomedical Research Center (BBRC) including the planning, resourcing, and execution of test plans.• Reorganized the related training programs to expedite BSL-2/3 training of new employees.• Received 3 outstanding performance awards: two were related to path work involving H5N1 and one for a safety suggestion that was accepted and implemented into department policy.