Pharmaceutical, quality, and operations

Wendy Meadows Davis

** ***** **** ****

Timberlake, North Carolina 27583

919-***-**** – ********@*****.***

Objective: To obtain a position that will enable me to utilize my skills, and training to be an asset to a growing company.

Training: Associate Degree in Medical Office Administration

Aseptic Processing

Six Sigma Green Belt Training and Certification

NC BioWork Process Certification

OSHA Lock Out/Tag Out

Adult CPR

cGMP (Good Manufacturing Practice)

Education: Piedmont Community College

Associate Degree in Medical Office Administration, 2014

Wake Technical Community College

Aseptic Processing, 2009

North Carolina State University

Six Sigma Green Belt Training and Certification, 2007

Durham Technical Community College

BioWork Certification, 2004

Employment: Corning Durham, NC

Quality Control Associate Sep. 2024-Present

Performs sampling of cell culture products per inspection plan for QC testing.

Review and verification of batch documentation, quality notifications, etc.

Completes production records/forms recording relevant data onto forms, ensuring accuracy and good documentation practices per cGMP standards.

Performs electronic transactions including creating notifications, lot reconciliations, product release, sampling plans and dispositions.

Open Book Extracts Roxboro, NC

Quality Control Specialist Nov. 2021-Sep. 2024

Ensure product quality and processes adheres to customer specifications and manufacturing requirements.

Adenosine triphosphate (ATP) swabs using Hygiena monitor

Calibrate scales throughout facility

Coordinate with department managers to develop, review and approve SOPs.

Ensure standardized tests on products meet standards and regulations regarding factors

including but not limited to: labeling compliance, product quality, consistency and other factors

such as chemical composition, sensory evaluation, and contaminant evaluation (microbiology,

residual solvents, heavy metals, pesticides.).

Review batch records and associated documentation, and assist with the CAPA (Corrective Action Preventative Action) program.

Water validation collection and testing using aseptic technologies including culture media plates, swabs, and pipette

GKN Driveline Timberlake, NC

Bill of Materials Administrator Apr. 2018-June 2020

●Manage bill of materials to ensure accuracy and consistency of the BOMs.

●Conduct weekly meetings to manage and review new engineering changes created by the application engineers.

●Develop, maintain, and enforce the use of corporate procedures and standards relevant to BOM product structure, etc.

Inventory Control Cycle Counter Jun. 2014-Apr.2018

●Locate and count inventory.

●Correct, investigate, and analyze inventory issues.

Eisai Durham, NC

Manufacturing Technician Oct. 2008-Apr. 2011

●Using cGMP, dispensed, weighed, documented, and inventoried raw material using SAP for the manufacture of oral dose tablets

●Using cGMP, operated Kikusui Press to compress oral dose tablets

●Using cGMP, completed and documented changeover for clean rooms

U.S. Flue Cured Tobacco Timberlake, NC

Records Keeper Aug. 2004-Dec. 2004

●Cataloged information on bales of tobacco using a scanner.

●Performed administrative tasks.

Vector Tobacco Timberlake, NC

Manufacturing Technician Oct. 2001-Dec. 2003

●Operated X-1 and X-2 cigarette packaging machine and cigarette maker.

●Organized stockroom.

●Assisted with receiving products.

●Documented information on tobacco.

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