Quality Assurance Operator

Kenneth L. Earley

215-***-**** Kenearl.early.gmail.com

Manufacturing Technician (Current temporary assignment) Medimmune Bio Pharmaceutical

Support all aspects in the manufacturing of Flumist to ensure product quality and safety

Support functions such as preparation of equipment and components to be used in the manufacturing of Flumist.

Operated equipment such as Autoclave Sterilization Chamber, Environmental monitoring equipment, Palltronic filter integrity tester, pH meter.

Formulating specialty cleaners and solutions needed for cleaning or to be used in the manufacturing processes.

Successfully completed aseptic operator training and aseptic gowning qualification to class 100 iso 5 clean room area's.

Able to work with computers navigating systems, recording data and information and finding information to accurately complete documentation to comply with FDA, GMP/GCP/GLP regulations.

A developed focus on effective communication both oral and written with the utilization of good listening skills.

Chemical Weighing/ Granulation operator I

(1991 - 2010) Johnson & Johnson McNeil CPC, Fort Washington, PA.

Lead operator on solid dose processing 2nd shift responsible for interacting with scheduling and component transportation to processing area.

Lead operator for the solid dose chemical weighing area responsible for ordering of components, weighing of shipping orders.

Resource for directing the other solid dose processing operators interacting effectively in a team environment to ensure all departmental and organizational goals are met.

Provided chemical weighing support in liquids during capacity constraints.

Assisted management in event investigation to prevent costly destruction of product.

Responsible for managing inventory in the chemical weighing area.

Operate control panel & computer systems (CRISP&EBR) by which the equipment would run to produce quality granulation product.

Operate & Maintain all lateral equipment i.e. pumps, solution tanks, meters, spray nozzles that work in tandem in the granulation process.

Strong ability to use hand tools for adjusting, repairing, assembling & disassembling equipment. And to assist and train others as needed.

Strong Mechanical/analytical abilities and to perform math function manually and with a calculator.

Forklift Certified to perform typical material handling activities.

Packaging Line Operator I

(1981 - 1991) Johnson & Johnson McNeil CPC, Fort Washington, PA.

Lead operator responsible for production goals of packaging bottle, liquid, pouching & vial tablet lines.

Responsible for Quality Assurance of production process.

Responsible to provide leadership & promote team work to a crew of line monitors in the performance of their duties.

Assist Mechanical Support in trouble shooting, adjusting, and repairing line equipment

Loom production floor Supervisor

(1974 - 1980) Penn Emblem embroidery, Philadelphia, PA.

Education Cheyney State college, Cheyney, PA.

(1971 - 1973)

Lyons Technical training, electrician program

(1985 - 1986)

Interests Professional Particle coating technician. Always striving to work in a team oriented environment. Carpentry, plumbing, electrical projects.

References References are available on request.

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