Cory Bartlett LSSMBB

• ~Lean Six Sigma~Quality Systems & Compliance~Leadership~Team Building~Process Improvement Expertise

1.) Merck Pharmaceuticals, Jaffrey NH~Lean Six Sigma Black Belt-QC Associate

2.) DuPont Pharmaceuticals, Billerica MA~Microbiology Associate Scientist

3.) Bayer Pharmaceuticals, Fitchburg MA~Quality Control/Quality Assurance

4.) Lonza Biologic, Special Modalities (LSA), Portsmouth NN QA Systems Manager

~Completed 40 Lean Six Sigma Projects with total ROI exceeding $25 Million, including a Process Capability Study on Viresolve Pro, saving over a $1,000,000 on each batch.

~Trained in teaching complete DMAIC methodology including LEAN to include a full day and half day agenda.

~Played a key role in implementing the Total QMS at Merck in the Membrane Analytical Laboratory in 2022, working with five different shifts

~Trained and Experienced in External Manufacturing as well as API/Drug Substance (Active Pharmaceutical Ingredient) to include Cardiolite and Aspirin.

~Trained and Experienced in Small Molecule Production and Manufacturing as well as Contract Development and Manufacturing Organization (CDMO) with DuPont Pharmaceuticals

~Highly trained, with over 30 years of experience, in all aspects of cGMP, cGDP and cGLP

~Applied Quality Control Tools and Techniques, Six Sigma and Lean framework at Dupont and Merck

~Proven Time Tested Team building experience, promoting daily, a Culture of Quality and Continuous Improvement, motivating, mentoring and managing team members using process and performance metrics to drive change and continuously grow each and every day.

~Strong knowledge base in Project Management, both waterfall and agile, with an applicable understanding of corporate alignment and strategic planning.

~Deployed Project Charters at both Dupont Pharmaceuticals and Merck using standard deployment technique-Performance, Cost and Time, reducing variation, defects and money ($294,000 Projected for 2023)

~Skilled, refined and battle tested in creating a Culture of Quality, Value-Added, Voice of the Customer, Right the first time working environment with 29 years of experience.

~Skilled in Value Stream Mapping, Process Mapping and Standardizing Procedural and Process improvements with proven track record at Merck, DuPont and Bayer Pharmaceuticals

~Highly developed written and verbal communication skills, communicating with both internal and external customers as well as upper management

~Would interface with multiple functional areas and staff members on a daily basis, serving as the Voice of The Customer (VOC), Quality Control SME, Project Manager and the Continuous Improvement Specialist.

~Reported monthly and quarterly Quality Control metrics to Director of Corporate Quality Operations

~Initiated and verified Change Control documentation to include TrackWise for Deviations, investigations and CAPA

~Used Excel, MiniTab, Smartsheets, Power BI and Microsoft Projects to manage and oversee all Quality records and various performance metrics for accuracy and compliance at Merck in 2021 and 2022

~As the Continuous Improvement/Lean Six Sigma Black Belt regularly met with Customers to discuss possible changes, metrics of concern, projects or any deviations, CAPA, investigations or other relevant issues

~Cross Functionally facilitated all Quality Control Project Meetings as well as Process Improvement meetings in 2022 and 2023 as the Lean Six Sigma Black Belt.

~An empathetic and experienced agent of change, equipped to generate value and customer satisfaction in any process.

~A dedicated Leader with a foundational gift to listen and relate on a personal level.

~A Detail oriented self starter with strong organizational skills

~Ability to handle multiple issues cross functionally with a high degree of accuracy (problems, projects, personnel, equipment, etc.)

~Supported department leaders in Lean deployment and implementation, problem solving methodology and change management-very analytical and data driven

~Partner with Functional leadership to help orientation and training regarding policies, regulations, procedure, clinical record structure and documentation standards applicable for pre-clinical and clinical GXP activities.

~Direct and facilitate strong cross-functional communication by building working relationships across the organization.

~Directed growing Quality department programs by serving as the Key Subject Matter Expert and implementing fit for purpose standardized processes.

~Oversaw and drove a Culture of achievement and accountability with DuPont and Merck.

~Oversaw collaborations with finance, functional heads and team representatives to develop and manage program budgets and scenario planning at DuPont.

~Cross-functional support for all relevant Quality GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH, ISO).

~Oversaw development and maintenance of Quality documentation, coordinated document development, assuring proper reviews, approvals and training programs.

~Developed, tracked and routinely published Key Quality System metrics and data at both DuPont and Merck.

~Directed Continuous improvement of Quality Systems to assure quality and adherence with GMP and inspection readiness.

~Directed and supervised employees to ensure daily performance was appropriate to department and organizational goals and objectives.

~Created assignments for employees in an efficient and equitable manner to achieve quality performance and align with company and department goals and objectives.

~Provided instructions, explanations and performance evaluations

~Directed and advised employees of performance requirements and review work status progress for individual and group basis.

Lean Six Sigma Master Black Belt Professional-Internationally Recognized MSI Certification ID#184728252