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Microbiology Supervisor and lab Manger of R&D Lab operations and marke

Location:
Rochester, NY
Posted:
February 13, 2014

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Resume:

Patricia A Walsh

**** ******** ** **********, **

315-***-****

accnrc@r.postjobfree.com

www.linkedin.com/in/patriciawalsh

Summary of Qualifications

Supervisor and laboratory manager with extensive bench expertise in microbiology. H ighly motivated

team player that excels at problem solving and product development. Comfortable and flexible in either a

bench, managerial, or mixed setting. Knowledge of ISO/GLP/GMP/NELAC/ASTM procedures. Familiar

with CAPA/NC/PeopleSoft systems.

Competencies:

- Laboratory Supervision - Method and Equipment Verification/Validation

- Logistics Management - Controlled Document Management

- Data Analysis - Project Management

Professional Experience

2005 – Present

Bausch & Lomb Rochester, NY

Supervisor, R&D Microbiology Lab Operations and Sterility Support

Supervise technical staff responsible for cGMP testing and lab operations microbiology department for

developmental, marketed product stability and product release testing.

Manage daily laboratory operations including scheduling, materials ordering, and instrument trouble

shooting. Responsible for budgeting of lab supplies and equipment upgrades for multiple departments.

Reduced departments lab supply operating cost by 20% over three years.

Deliver microbiology method development and marketing support for Vision Care and Pharmaceutical

business units. Presented at national and international scientific conferences supporting existing and

new product launches.

Serve as a Microbiology team representative on key new product development projects for Vision Care

and Pharmaceutical Divisions.

Review and approve pertinent documentation to ensure compliance to internal and external

requirements.

Coordinate validation methodologies for new methods, method transfers to manufacturing sites

and external labs, and qualifications for new and existing equipment.

Oversight for the departments Nonconformance and CAPA Systems as well as the departments

Quality Change Request system.

1990 –2005

Eastman Kodak Company Rochester, NY

Microbiologist

Directed and delegated projects to technical staff to maintain workflow in a timely manner.

Managed daily laboratory operations including scheduling, ordering, instrument trouble shooting and

budgeting resulting in a 47% productivity gain for 2004.

Assisted research and development activities for established products as well as potential new

business ventures. Contributing author on patent for first phase, novel silver antimicrobial product.

Research work resulted in 5 year 13 million dollar contract with outside vendor for the novel silver

antimicrobial product.

Successfully promoted laboratory services and value to internal customers resulting in a work flow

increase of 8% for 2004 and creating $150 thousand revenue for the department.

Responsible for analyzing products for microbial issues using standard and modified microbial

methodologies. Updated the laboratory with new technologies to better meet customer needs.

Technical leader and team member on numerous problem-solving teams.

Served as the global lead for harmonizing microbiology methods and technologies in US and

international company laboratories.

Bausch & Lomb Rochester, NY Summer 1989

Laboratory Technician

Environmental monitoring of clean room production areas.

Sterility testing of products.

Nalge Co. Sybron Corp Rochester, NY Summer/Fall 1988

Laboratory Technician

Quality Control and Developmental Testing.

Customer Complaint Investigations

Sales Staff Training on Products

Praxis Biologics Rochester, NY Fall/Winter 1987

Laboratory Technician

Stability testing using titration methods

Quality control methods

Education

University of Buffalo Buffalo, NY 1990

Major – Biology, (Chemistry minor)

BA

Monroe Community College Rochester, NY 1987

AAS Biotechnology

Professional Development

Aseptic Processing Training Program - June 2013

Leadership Development –June 2012

Technical Writing and Concepts – January 2012

Product Development Process – September 2011

Product Development Management Process – September 2008

Six Sigma Green Belt - October 2003



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