Stephanie E. baker

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

Toledo, OH 43614

Mobile: 419-***-****

abl8ng@r.postjobfree.com

Profile

I am an accomplished, energetic manager with

extensive experience in quality assurance/quality

control. I am a goal-oriented professional with

strong leadership skills, which involved

supervision, customer service, strategic planning,

continuous improvement, and organizational

decision-making. Additionally, I possess

administrative skills as well as interpersonal

skills that will contribute to the success of an

organization.

Experience

2008-present Talecris Plasma Resources Toledo, OH

Quality Supervisor II

A network of plasma collection centers and a wholly

owned subsidiary of Talecris Biotherapeutics, Inc.

Responsible for uncompromising commitment to

quality and strict adherence to all regulations and

guidelines governing plasma collection. Product

safety, quality, and effectiveness are the most

basic and important considerations.

Responsible for planning, implementing, &

administering the quality assurance program, which

includes analysis tracking, CAPA, and adherence to

quality standards.

Responsible for ensuring all operations complies

with all federal, state, & local regulations and

TPR procedures and policies.

Responsible for procedure updates & validation,

including staff training & performance measures.

Responsible for continuous improvement efforts

within organization.

Designated trainer

FDA & customer service interface.

2006-2007 Heartland Repack Services Toledo, OH

Quality Control Manager

A pharmaceutical repackaging firm of both

controlled and non-controlled drug products.

Responsible for Quality Control Systems of

organization.

Responsible for procedure updates and continuous

improvement efforts.

Set and communicated clear priorities and standards

of performance and expectations.

Performed internal audits, corrective and

preventive actions for quality systems and

compliance concerns.

Trained, developed, supervised and evaluated the

performance of 10 direct reports and 2 indirect

reports.

Skilled in developing and implementing standard

operating procedures and policies.

FDA and customer service interface.

1997-2005 The Andersons, Inc. Maumee, OH

Laboratory Manager

A producer of lawn fertilizers, which also provides

industrial and commercial corncob stocks processing

services.

Increased productivity and retention of finished

products through the introduction, implantation and

facilitation of the restructure of the QA

laboratory in order to produce accurate and timely

analysis to support efficient manufacturing

operations.

Defined and established specific quality

assignments, responsibilities and goals. Skilled in

developing and implementing standard operating

procedures and policies.

Provided guidance and training to staff on control

plans, FMEA, SPC, capability analysis, and quality

measurement systems for 7 direct reports.

Responsible for recommending and supporting

continuous improvement and quality initiatives.

Performed validation procedures on analytical

instrumentation.

Had customer interface through Contract

Manufacturing Systems.

Performed duties of a liaison effectively with

manufacturing and production, research and

development, and quality department and supplier

quality to identify and fully satisfy quality and

supplier requirements.

Performed and continuously improved internal audits

to assure the highest level of quality systems

compliance for the company.

Education

JUNE 2010 UNIVERSITY OF PHOENIX PHOENIX, AR

Pending Doctorate of Management; Organizational

Leadership.

2006 Heidelberg College Tiffin, OH

MBA, Business Administration.

1997 University of Toledo Toledo, OH

M.S., Chemistry.

1992 University of Toledo Toledo, OH

B.S., Chemistry.

professional development

Extensive CAPA, SPC, GMP, GLP, Hazardous Waste

training and audit experience. Trained in Lean

Manufacturing, ISO 9000, GLP, Six Sigma, and Total

Quality Management.

Strong computer, analytical, customer service and

project management skills.

Coaching, mentoring, and team-building skills as

well as conflict management skills.

Contact this candidate