Defined and implemented LEAN processes including simplified forms, SOPs, a food bank Kanban and FIFO system, financial controls, and accountability for a food bank service organization. New processes resulted in time and financial savings and a site award for “model food bank” due to efficiency.Developed novel electronic batch record solutions compliant with ANSI 88 for Class I, II, and III devices, pharmaceuticals, and biologics which included unique AQL and continuous manufacturing data capture features. Out of the box client-customizable software with patented design module to develop master batch record or master device record which integrates with established QMS software modules, LIMS, and ERP systems for maximum efficiency. Designed system to eliminate common human errors by automating routine QA and manufacturing tasks such as training checks, calculations, specification comparisons, yield calculations, and sampling sizes. Worked with UDI regulation implementation to capture new product information in system. Assisted clients with part 11 compliance for regulated databases.Firsthand experience with products regulated in the US and Internationally. Specific expertise includes Quality System development & implementation, change control, document controls, SOP & Protocol development, design controls, Audit readiness, external inspections, training, FDA inspection readiness training & preparation, FDA 483/Warning Letter responses and remediation, new product launch, QA/QC investigation and CAPA, complaint handling, recall process development, Project management, lot release, and ANSI 88 batch controls. Direct experience with FDA, TGA, BSi, Medcert, TUV, KEMA/DEKRA, PA Board of Pharmacy. Product experience includes Class I, II, III medical devices, combination drug/device/biologics, drug/device, (IVD kits, infectious disease blood testing, balloons, stents, drug eluting stents, catheters, surgical gloves, OTC home-testing kits).

Expert Quality and Regulatory Compliance consulting for Pharmaceutical, Bio-pharmaceutical, Medical Device & IVD companies. Specializing in Quality System and SOP Development, document controls, project management, FDA remediation, QMS implementation, training, inspection readiness, combination products, implementation of electronic systems, and LEAN manufacturing.Worked with companies to prepare for FDA inspections and regulatory filings. Developed and wrote new ISO13485:2016-compliant quality system for company entering the US market for the first time. Implemented inspection plans and directed back room operations during successful notified body audit and unannounced FDA inspection. Managed project and wrote SOPs for integration of existing manufacturing business into brand new quality system. QSR audit and writing of SOPs for foreign company entering US market and company site expansions- specifically recalls, complaints, annual product review, and general QA procedures. Performed CAPA review and recommendations for improvement as part of an FDA remediation. Analyzed market opportunities for new products across device and pharmaceutical sectors. Served as project manager for quality enhancements and FDA 483 response/remediation projects. Wrote FDA response letters for 483 remediation. Conducted QSR/cGMP training. Helped clients implement new document control software and improve quality system documents. Provided training for new software systems and helped transition employees to electronic systems. Defined and implemented electronic processes for document control and training using electronic routing and signature processes in compliance with Part 11.

Operational oversight, staffing and management of quality and regulatory consulting projects supporting the life science industry. Ensure successful completion and closeout of projects. Manage daily interactions with consulting staff of up to 150 consultants. respond to project requests for additional resources or specialty resource assistance (micro/aseptic/ validation/ etc.), maintain open communication with all clients regarding project staffing and availability. Oversight of operational excellence and client satisfaction.

Tutor for math and science curriculum from junior high through college level. Curriculum selection, lesson planning, and instruction for private math classes.

Drive systemic improvements in change management, training, documents/records, and complaints through redevelopment of quality system. Responsible for development, staffing, and strategy for group of 11 employees including QE, document control, and product release. Direct MasterControl™ electronic QMS implementation and integration with SalesForce.com software. Participate in and lead Kaizen events in QC laboratory resulting in $100K savings with a yearly goal of $5M. Standardize audit process to handle requests and setup. Resulted in site prepared to handle unannounced FDA inspections. Coordinate three on-site audits by FDA and notified bodies. Develop and implement compliance-related training. Serve as quality representative to new product teams responsible for new product risk analysis and FMEA updates to established products to comply with ISO14971:2007. Provide quality and compliance direction to new product and transfer teams including academic partnerships and CLIA product development. Develop brand new quality system for CLIA laboratory implementing a clinical trial. Participate in management review, regulatory submissions, clinical trial design, and FDA and third-party audits. Diverse product offering of diagnostic tests from drugs of abuse to Alzheimers, women’s health and cardiac.

Responsible for development, staffing, and strategy of new QA group in charge of annual product review, validation review, new product development QA, GLP QA, and product release for 1000+ part numbers of sterile, implantable Class III and combination Class III products. Initiate teams for LEAN QS process improvements leading to $112M annual savings. Part of world-wide integration team preparing QA to handle holds, inventory, and release with no business interruption in 2 months. Identify new product cost drivers for monthly COGS metrics, establish budget and headcount forecast. Develop compliance metrics for group including TAT, pareto of errors, and root cause trending. Participate on team for electronic batch records deployment. Responsible for manufacturing and laboratory data review for all analyses for recall decisions. Serve as lead QA reviewer for GLP studies and train team in 21CFRPart 58.35 responsibilities including master schedule maintenance, study data review, and pathology observations. Coordinate and perform technical internal audits for all analytical laboratories. Serve as lead auditor for contract stability facility. Responsible for controlled access areas for product retains, product holds, and product investigations. Serve as QA for new product team developing combination biologic/device. Responsibilities included SOP writing and review, training in biologics regulations and BSL safety, review of clinical trial design, review of product design and specifications, oversight of all product development phases for implementation of biologics regulations and guidances. Contribute to PMA submission and CMC sections. Align QA at US and EU sites. Train transfer teams for multiple successful clinical trials and product launches. Review and approve CAPA and management review. Provide direction to up to 28 employees.

Participate in development and implementation of new QA process group and QS improvements. Responsible for product data trending/analysis, SPC, specification setting, and sample size selection. Responsible for all data tables and summaries for CMC section of IDE for combination product. Present technical and clinical readiness summaries to Sr. Management and Technical groups as part of design control. Lead failure investigations using Six Sigma. Develop rework protocols when new updated labeling required by regulation which lead to successfully reworking product with no compliance errors. Lead product and stability OOS investigations. Review and approve all process characterizations and validations. Serve as compliance advisor and QA reviewer for production, process development, laboratory, and clinical research groups. Quality liaison with New Ventures research group to ensure quality design.Lead training in compliance, project management, and other topics. Apply ISO13485 and cGMPs phase-appropriate compliance to multiple DES (drug/device), biologic/device, and other Class III devices. Active member of MSRB.

Responsible for establishing specifications, performing qualification, and release of materials used in an implantable combination drug/device using AQL. Implement drug regulations for combination device compliance including writing new analytical laboratory method validations, OOS procedures, and statistical analysis for new product specifications. Assist in failure investigations, CAPA, and planned monitoring. Facilitate change control by reviewing and approving site procedures, method validations, OOS, and equipment qualifications. Work with engineering to develop process improvements, characterization, and validations using DOE. Develop specifications for clinical materials. Participate in process FMEA and risk analysis. Review DI/OQs for equipment. Teach annual cGMP classes. Responsible for supervision, career development, and scheduling of non-exempt direct reports.

Responsible for documentation review and other related activities to ensure compliance with company procedures, QSRs, cGMP, and ISO quality requirements for combination biologic/drug/device. Batch record/lot release responsibilities including product hold and investigations. Interact with all departments as Quality lead ensuring timely product release for clinical trials. Coordinate effort to train project personnel in quality procedures. Products included IVD and blood screening tests and all reagents and associated instrumentation.

Develop test method for materials to save the company money by identifying faulty vendor lots. Contribute testing data for clinical lots used to support an FDA biologics license application (BLA). Develop method for a novel HIV/HCV blood screening diagnostics assay. Responsible for analytical testing of nucleic acid diagnostics. Develop purity and identity analytical test methods and validations to transfer to QC, troubleshoot all R&D methods and materials. Write new QC analytical procedures for all new test methods. All work performed in BSL 2 and BSL 3 environments. Responsible for lab and chemical supplies budget.

Project lead responsible for Design History Files and coordination of international development team for international transfer of new Class II medical device from R&D to manufacturing. Worked with international team to help troubleshoot manufacturing process failures by investigating potential sources of contamination or process differences and recommending process and formula adjustments to eliminate the problem during setup and scaleup of new product manufacturing lines. Also responsible for curriculum development for sales force product training, data summaries supporting patent defenses, product development and improvements, troubleshooting manufacturing processes, conducting product competitive analysis, developing and writing new test methods, equipment and supply records, process validation using ASTM standard tests, manufacturing feasibility and scale-up of Class II devices, evaluating results, and planning experiments.

Under the direction of a PhD scientist setup lab, synthesize and characterize two novel compounds using copper and rubidium cores, findings presented for Janicki Foundation research award and journal publication, elected as a member of Sigma Xi.

Develop customer relationships to assess product needs then design product improvements. Work on products for military and cell phone applications. Design new hire training program to teach product/process information and company policies.