Director, Qa/QC

JEANNIE METZINGER

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

Dresher, PA *9025

215-***-****

****************@*****.***

DIRECTOR OF QUALITY ASSURANCE

Risk Analysis...FDA Regulatory Compliance...Testing

Validation...Planning...Safety...Kaizen

Lean Six Sigma...Documentation...Productivity

International...Training...Team Leadership

I have routinely served as the planner and driver

of QA / QC and compliance initiatives that turned

marginal performance into global benchmarks in the

most regulated industry in the world. I mastered

and effectively leveraged both the science and the

process skills vital to company performance in zero

defect environments.

Developing and maintaining successful quality

management systems

Creating strong QA partnerships with Operations and

Manufacturing

Strengthening international quality management

control

Creating best practices-oriented operating

cultures

Ensuring regulatory compliance

I have an MS in Quality Assurance and Regulatory

Affairs from Temple University, and a BS in Biology

from Holy Family University. In addition, I am

trained in Kepner Tregoe problem and decision

analysis methodology, Lean Six Sigma, and Kaizen. I

am skilled in trade risk analysis to protect

international shipments against terrorism.

CAREER HISTORY

Director Quality Control / Quality Assurance

Americas, Colorcon, 2008 to 2009. Promoted to

maintain Good Manufacturing Practices (GMP),

quality control and regulatory compliance for this

provider of pharmaceutical chemical’s North

American, Puerto Rican and South American

operations. Controlled $4M budget. Led staff of 50.

Director Quality Control / Quality Assurance North

America, Colorcon, 1997 to 2008. Ensured quality of

product and process stability, validation, internal

and customer audits, and analytical and

microbiological testing. Created new hire readiness

training program endorsed by FDA. Managed $3M

budget and staff of 40.

Technical Services Manager Liquid and

Dermatological Products, Novartis, 1995 to 1997.

Directed critical elements of manufacturing

process, including scheduling, testing and

prioritization. Planned and directed process and

equipment validation. Oversaw packaging line

producing blister packs and bottles. Headed team of

25.

Prior Assignments: Quality Manager and Document

Control Manager, Rhone Poulenc Rorer. QC Analyst

and Product Release Auditor, William H. Rorer Inc.

Analyst, Westinghouse Nuclear Reactor Division.

Contact this candidate