L Winfield
Continuous Improvement and Quality Professional
Knightdale, NC 27545
lwinfield1382@gmail.com – (910) 233-6033

Quality professional with experience in Quality Control and Quality Assurance functions, and most
recently Continuous Improvement. Responsibilities have included investigating customer complaints
and internal non-conformances, root cause determination, identification and implementation of
corrective and preventive actions, and assisting in facilitating internal, customer and vendor
audits. Also, achievement of certification to ISO 9001:2008. Skilled in building relationships with
all levels of personnel to achieve quality and compliance goals.
Authorized to work in the US for any employer

WORK EXPERIENCE
Continuous Improvement (CI) Specialist 3
RR Donnelley  –  Durham, NC – September 2013 to Present

• Analyzes current systems and recommend improvements
• Collect data and develop metrics for process measurement and identification of improvement
opportunities
• Facilitate certification to ISO 9001:2008
• Facilitate implementation of relevant cGMP practices
• Generate the Internal Audit Schedule Annually and act as Lead Auditor
• Develop and deliver Quality Systems and Internal Auditor training
• Host customer audits
• Assist process owners with root cause and corrective action determination
• Facilitate Corrective Action Review Board (CARB) and Management Review meetings
• Perform various administrative and ad hoc projects as required

Platform ISO 9001:2008 Quality Lead (09/2014 – 05/2016)
• Coordinate the activities of ten (10) plants to meet corporate and certifying agency requirements
• Implement standard practices throughout the platform
• Generate the Inter-platform Audit Schedule and act as Lead Auditor
• Host corporate and certifying agency audits
• Monitor and review corrective action plans for adequacy
• Mentor newly appointed site ISO Management Representatives

Supplier Quality Specialist
Hospira, Inc.  –  Clayton, NC – March 2012 to September 2013

• Authored Supplier Quality Agreements (SQA)
• Participated in supplier change notification review
• Revised Material Specifications and Standard Operating Procedures
• Conducted Supplier / Material Impact Assessments
• Audited Suppliers for Conformance to Regulatory and Company Standards
• Conducted Internal Audits and Assessments
• Oversaw the Backroom during Regulatory Inspections
• Compiled Metrics for Corporate Supplier Quality

Regulatory Compliance Technician
Hospira, Inc  –  Clayton, NC – August 2010 to March 2012

• Assisted in Developing the APQR Format and Process
• Acquired, Compiled and Analyzed Data for Annual Product Quality Reviews (APQR)
• Presented Completed APQR reports to Management and External Regulatory Agencies
• Used TrackWise to Review and Initiate CAPAs
• Assisted in Facilitating Inspections and Audits

Compliance Specialist
Tecan US, Inc  –  Durham, NC – September 2008 to August 2010

• Investigated and determined root cause for medical device customer complaints
• Performed effectiveness verifications
• Maintained the training matrix and ensured requirements were met
• Delivered Quality Systems training
• Completed vendor surveys for supplier qualifications
• Initiated and reviewed Supplier Corrective Action Requests (SCARs)
• Ensured calibration of equipment
• Performed quality data processing using the electronic systems SAP and DataSweep

EDUCATION

MBA
North Carolina State University – Raleigh, NC 2013 to 2016

B.S in Biochemistry, Microbiology  – North Carolina State University – Raleigh, NC December 2004
CERTIFICATIONS

ASQ Certified Quality Auditor
June 2010 to June 2016
This certification indicates an understanding of the standards and principles of auditing and the
auditing techniques of examining, questioning, evaluating and reporting to determine a quality
system’s adequacy and
deficiencies.