Michelle S. Smith has over 20 years of experience in quality assurance and training roles in the pharmaceutical industry. She currently serves as the site lead for training and development and quality systems at Fresenius Kabi, where she manages project deliverables and ensures regulatory compliance. Previously, she held similar roles at BD Rx and Grifols, where she developed quality systems, led audits, and oversaw training programs. She has expertise in a variety of quality systems and holds a Bachelor's degree in Biological Sciences from North Carolina State University.

1. Michelle S. Smith
4180 NC HWY 222 East, Stantonsburg, NC 27883 (919)369-6168 E-Mail:● ● mlsmith1130@yahoo.com
Synopsis
Current site lead responsible for the management of Training and Development and Quality Systems for the last 4 years with a focus on
management and leadership. Development, creation, and ownership of multiple quality systems. Excellent written and oral communication
skills with the ability to interface efficiently across multiple departments and sites. Adaptive and quick learner with capability to multi-task to
meet deadlines while still upholding quality standards.
Achievements
• SME in the following areas: Quality Assurance: Management of Change Controls and Deviations, GXP Training, People Management,
Facility Systems, Project Management and Supply Chain/Logistics
• Leadership in Pharmaceutical Regulations and Quality Systems which includes: Documentation Management, Internal/External
Auditing (FDA, DEA), TSA certifications and program manager, Investigations, Annual Product Reviews, GXPs, Safety, Batch Release,
Validation, Critical Utilities, Employee Management and Development
• Expertise in Quality Procedures, Processes and Systems across multiple functional departments
• System expertise: ExcelSafe, Trackwise, SAP, DMS, ComplianceWire, Plateau, Maximo, LIMS
Professional Experience
Fresenius Kabi LLC, Wilson, NC 2016 –
Present
BD Rx, Wilson, NC (acquired by Fresenius Kabi LLC 01/2016) 2013 –
2016
Quality Systems (Internal Audits, Change Controls, Complaints System Owner)
Training and Development (Site Management/System Owner)
Management of Site Training and Development and Quality Systems
• Manage project deliverables and timelines to ensure compliance with regulations, procedures, and best practices (process flow, root
cause analysis, trend analysis, process improvement)
 Manage and maintain the site change control system and communication for global changes
 Development/Validation of Trackwise system for Change Controls
 Provide metrics for Quality Management Review information for change controls and site training
 Manage and maintain product complaints including incoming complaints, investigation process, final complaint summary, metrics,
and final communication
 Manage and develop site training system (cGMP, tracking, development, multiple sites)
 Manage internal audit program and develop audit training for the site
 Compliance development for Critical Utilities and Periodic Review comparison
 Perform Periodic Reviews and Annual Product Reviews for site product schedule
Grifols (Talercris), Clayton, NC
Sr. Technical Training Specialist 2007 – 2013
Manage and maintain change controls, investigations, training and TSA program for Supply Chain/Logistics, Warehouse
 Manage and maintain Change Controls throughout its lifecycle: creation/revision, review and approval, effectivity, obsolescence, and
assignment to appropriate employee job functions
 Lead for internal and external audits (internal audit program, FDA, TSA, Vendors)
 Supervise, manage and mentor other departmental training team members to provide guidance and advancement
 Supervise site changes (SOPs and BPRs) to be current with company processes for employees and maintain regulatory compliance
 Lead the development of training plans for new products or significant process changes

2. Michelle S. Smith
4180 NC HWY 222 East, Stantonsburg, NC 27883 (919)369-6168 E-Mail:● ● mlsmith1130@yahoo.com
 Manage development of new employee training plans to effectively and efficiently orient to Business Unit
 Identify gaps and deliver and coordinate learning and learning solutions to address these gaps
 Accountable for independent decision making and representation of the Supply Chain department in cross-functional teams
 Identify and Implement Safety/Technical training elements and Manage the tracking of employee training
 Quality Stewardship Supply Chain site representative for site improvement projects
 Manage the Maximo work order request for Supply Chain department
Talecris Biotherapeutics, Clayton, NC
Quality Associate II 2005 – 2007
Project Manager for multiple Quality Projects, SME for batch review and release, cGMPs and Safety Training
• Develop, implement and evaluate training programs across the site
 Implement Change Controls for Supply Chain department (revision, supervise, follow-up)
 Project Lead for Supply Chain area improvements and upgrades
 Provide quality support in complex projects utilizing internal and external resources
 Work with internal and external contacts with the review and release of product
 Perform review/audits documentation, center status, and temperature status of all documents associated with vendor batches
(follow-ups according to cGMP and SOP requirements)
 Review drug product batch records, associated documentation and test and inspection data for cGMP and specification compliance
to approve/reject product
 Identify areas of non-compliance or opportunities for continuous improvement and worked with departments to achieve resolution
Bayer Healthcare, Clayton, NC
Validation Engineer 2004 – 2005
 Schedule and execute validation studies, protocols, project, production and revalidation requirements
 Evaluate and analyze data collected during projects, verify adequacy, compliance with regulations, author final reports, and
assemble validation packets
 Prepare, program, maintain, and use data acquisition systems for validation of equipment and processes
Carolina Turkey, Mt. Olive 2004 – 2004
Quality Supervisor
Supervisor of a team of multiple direct reports to organize their daily functions
 Supervise QA Technicians in daily responsibilities (GMP, HACCP, AND SSOP activities)
 Provide guidance to Operations management to assure compliance in maintenance of company policies and programs
 Provide metrics to production and management to identify activity trends
 Conduct training and cross training of QA technicians
 Provide QA involvement in the Plant Improvement, Trim Performance, Foreign material reduction, and Production KPI, sanitation and
safety
Purdue Pharmaceuticals, Wilson NC 2003-2004

3. Michelle S. Smith
4180 NC HWY 222 East, Stantonsburg, NC 27883 (919)369-6168 E-Mail:● ● mlsmith1130@yahoo.com
Training Specialist, Quality Assurance
 Develop, Manage and Implement Training Department for documentation, tracking, filing system, and certifications
 Administer and maintain the SAP Qualification Management System
 Assess training alignment between sites (member of site training team) and ensure compliance to all regulatory requirements
Quality Assurance Specialist 2001-2003
 Supervise audit team to strengthen the current program and conduct internal audits of the facility, provide follow-up to ensure
implementation was effective
 Prepare, review and approve deviations, investigations, customer complaints, and Annual Product Review
 Author, perform review for compliance to cGMPs, and approve documentation
 Sample, perform inspections and review QC laboratory inspection data for raw materials and packaging materials
 Approve drug product batch records, associated documentation, inspection data for cGMP and specification compliance to
approve/reject finished product
 Perform validation of Quality tracking systems to insure compliance
 Evaluate, revise and implement AQL/In-process practices for the packaging area
Education
North Carolina State University, Raleigh, NC, 1999
Bachelor of Science in Biological Sciences