Customer Service Medical Device

Patricia Mishkar

Wausau, WI

********@*****.*** - 779-***-****

Manufacturing and Quality Specialist with 20 years experience in FDA and DEA regulated medical device

and pharmaceutical environments. Focused on assurance of quality production processes and protocols in

dynamic environments. Demonstrated experience in the following:

Medical Device Manufacturing

Quality Improvements

Clean Room Environments

Standard Operating Procedures

Testing Protocols

Supervision

Training

Production Efficiencies

WORK EXPERIENCE

Production Supervisor

Merz Aesthetics - Franksville, WI - June 2005 to August 2013

Responsibilities

Managed first shift production team daily activities and coordinated manufacturing operations with 2nd and

3rd shift supervisors.

Trained operators in all aspects of Class 8 clean room production per FDA requirements for Class III medical

devices.

Ensured clean room operations conformed to production policies and procedures through operator guidance

and the participation in internal audits.

Established work and production priorities to meet fluctuating customer volume requirements.

Accomplishments

Recommended and implemented improvements to production policies and procedures resulting in production

efficiencies.

Created systems to track testing and results for production materials used to identify areas of improvement

in procedures, processing and training.

Implemented corrective actions to product non conformances as part of the internal quality improvement

procedures.

Participated in the development and implementation of operator process competencies including

implementation of training videos.

Trained facility employees to changing Standard Operating Procedures.

Coordinated the implementation of Engineering and Research and Development research testing resulting in

minimal impact to production scheduling.

Wrote and executed testing protocols for new clean room equipment being installed to standardize

manufacturing processes.

Customer Service Associate

Barnes and Noble - Wausau, WI - October 2004 to May 2005

Responsibilities

Assisted shoppers and cashiered while conducting job search.

Production and Shipping Associate

Hillestad Pharmaceuticals - Woodruff, WI - June 1993 to October 2004

Responsibilities

Produced vitamin and herbal supplements in an FDA and DEA licensed manufacturing facility. Shipped daily

orders worldwide.

Assisted in all areas of facility to meet production goals and customer requirements.

EDUCATION

BA in French

University of Minnesota - Duluth, MN

1988 to 1991

SKILLS

SAP, QAD, Master Control, Microsoft Word and Excel, GMP, ISO13485, Aseptic Techniques, CAPA

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