CAPA Coordinator Resume

SUMMARY:

I intend to leverage my experience and knowledge in the medical device and pharmaceutical arena. With a combined background in healthcare, FDA regulated pharmaceutical and medical device manufacturing environments, I excel at understanding customer needs and manufacturing requirements. I possess a high level of professional integrity and personal accountability.
I am a Certified Quality Auditor CQA(ASQ) accomplished in performing and overseeing internal audits and hosting many external auditing organizations (FDA, AABB, NRC, CLIA, Dendreon, etc). As a member and leader of many national and cross - functional teams I have excelled at engaging others to accomplish organizational goals. In addition, I have more than 12 years medical laboratory testing expertise MLT(ASCP).

PROFESSIONAL EXPERIENCE:

Confidential

CAPA Coordinator

Responsibilities:

In charge of logistics and support of the CAPA program
Coordinated day-to-day activities of the CAPA Board and special projects
High level interaction with cross functional directors, managers, and staff
Maintained data and visual management metrics
Coordinated routing of quality system documents in MRCS and TrackWise
Create CAPA/Nonconformance recordsExcelled at working independently under pressure in a dynamic environment
Developed processes related to the implementation of new CAPA process

Confidential

Senior QA Associate

Responsibilities:

Excelled at problem review and approval, closing over 7,500 problems and complaints. Identified hundreds of issues that needed formal CAPA resolutions, which led to continuous improvement in operations at the facility and throughout the organization.
Lead regional QA liaison for Babesia IND study.
Primary FDA point of contact (POC) for nonconforming product investigations and resolutions.
Lead QA contact for all testing and manufacturing consultations and discrepancy resolutions. Recognized as the “go to guy” for manufacturing issues and complex testing issues.
Excelled at building relationships with operational departments throughout the organization, driving continuous improvement initiatives.
In charge of statistical sampling performance to ensure organizational adherence to regulatory compliance.
Primary QA liaison for the Quality Control Laboratory (QC), providing QA oversight of all QC testing performed at the facility. The QC lab was repeatedly recognized as the benchmark performer for the organization.
Lead QA oversight of all Immunohematology Laboratory, Neutrophil Laboratory, and Platelet Serology Laboratory issues, discrepancies, and document development.
Lead numerous System audits to ensure compliance to procedures and regulatory requirements.
Material Review Board (MRB) primary member conducting suspect product investigation, resolution, and release.
Executed complete QA oversight of Level 2/3 problem investigations and CAPA implementation.
Excelled at identifying and down-grading hundreds of high level problems, saving the organization time and resources.

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