Donna Y Winfield

Cornelius, NC *****

ad1ztk@r.postjobfree.com

+1-716-***-****

Willing to relocate to: North Carolina - -

Authorized to work in the US for any employer

Work Experience

Document Control Coordinator

Charter Medical, LLC - Winston-Salem, NC

October 2023 to Present

Ensures effective control, distribution, traceability, retention and retrievability of documents and Quality records.

Engineering Documentation Coordinator

Curbell Medical - Orchard Park, NY

October 2022 to August 2023

My position is responsible for creating and maintaining engineering documents including drawings, specifications and engineering change control records. Conduct Engineering Change Order release .Track and maintain ECO’s. Compile all ECO’s documents for review, Assist in internal/external audits. Maintain and file all documents. Software used SAP, BarTender, MS office suite. Documentation Coordinator

Athenex Pharma Solutions - Clarence, NY

November 2019 to October 2022

Review and Analyze complex information and make judgement calls on all Batch records as per Current Good Manufacturing Practice. Followed all training on SOP per FDA rules. Make sure all corrections were made before deadlines. Maintained Quality management system (QMS) and associated processes while ensuring compliance to regulatory and customer requirements. Input inventory of final totals of products made into QMS system. ISO 13485 regulated environment worked on Quality Management System,MS Office suite. Assist in internal/external audits and supplying documentation as needed for FDA review. Quality Control Inspector Team Lead/ Process Operator Fresenius Kabi - Grand Island, NY

November 2016 to November 2019

Manage a quality control room of inspectors performed visual inspection of products. Completed daily documentation of all inspected, rejected products. Kept record inventory of all materials assigned to inspections rooms. Processed inventory for Controlled Substance in secured warehouse vault. Supervisor/ Poker Dealer

Seneca Nation of Indians Casino - Niagara Falls, NY May 2006 to January 2017

Responsibilities

Ensure optimal level of customer service, manage efficient dealing of poker games. Compliance to casino security systems, rules

Accomplishments

My impact is being part of a Customer Success Team. A great work ethic and a willingness to do what needs to be done.

Skills Used

Detail-oriented, Organized, make decisions, be precise, work quickly, flexible and adaptable, willingness to learn.

Quality Assurance Technician

American Axle & Manufacturing - Buffalo, NY

January 1999 to June 2005

Documenting and reporting product quality levels. Implementing standards for inspection. Helped company reduce waste. Worked in anti- corrosion paint facility for gear axles. Education

High school diploma

Grover Cleveland High School - Buffalo, NY

Skills

• Communication skills

• Customer service

• Microsoft Excel

• Computer skills

• Master Control (6 years)

• Medical Records

• Documentation review

• Windows

• CPT Coding

• Leadership

• Quality control

• Supply chain

• Risk management

• Banking

• Conflict management

• CGMP

• Medical Billing

• Quality assurance

• Quality management

• Packaging

• Filing

• Auditing

• Laboratory Experience

• HIPAA

• EMR Systems

• Continuous improvement

• Manufacturing

• Math

• Supervising experience

• Warehouse management system

• Warehouse experience (3 years)

• ISO 9001

• FDA regulations

• English

• Quality inspection

Awards

Instructors Award

December 2015

Certifications and Licenses

Medical Billing / Coding Certification

January 2015 to December 2015

Contact this candidate