Quality Assurance Technician

LILESHNI SINGH 510-***-****

cell

HAYWARD, CA **544

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

OBJECTIVE: A position as a SENIOR PHARMACEUTICAL MANUFACTURING TECHNICIAN

PROFESSIONAL EXPERIENCE:

Manufacturing Process Technician, Impax Pharmaceutical Labs, Hayward, CA

2007 to 2013

. Prepared equipment and room log books for process room release.

. Reviewed Manufacturing Batch Record for specific requirements and

deviations.

. Qualified Subject Matter Expert in the operation of Granulator (PMA).

. Trained technicians in the operation of the Granulator.

. Qualified in the operation, disassembly, cleaning and assembly of

various manufacturing equipment such as milling (Comil, Fitzmill),

screening (Vibroscreen), blending (Up to 60cft Blender), spray

nozzles, ovens and weighing.

. Operated equipment using the standard parameters or as specified in

the Manufacturing Batch Record with emphasis on critical process

parameters.

. Followed SOP and CGMP on the manufacturing floor.

. Was trained regularly on SOP changes and overall improvements.

. Prepared solutions for granulation.

. Performed calibrations for solution flow rates and scales.

. Checked material for level of dryness using moisture analyzers.

. Calculated batch factor for mass adjustments.

. Performed batch record reconciliations and reviewed for accuracy and

completeness.

. Prepared and assisted QA for Batch Uniformity sampling to assure blend

uniformity.

. Released rooms and major cleaned equipment.

Order Processor, Exp Pharmaceutical, Fremont, CA

2004 to 2007

. Inputted NDC's via 10-key experience or by bar code scanner.

. Sorted products using sorters manual return policy.

. Keyed small items using manufactures return policy.

. Printed reports, inventory lists and packaging products.

. Experienced in handling scheduled and non-scheduled substances.

. Maintained and exceeded productivity and accuracy.

. Assisted shift lead in the training of personnel in Able processing

procedures.

. Pulled orders and quality assurance.

EDUCATION:

Cornerstone College of Science & Technology, Hayward. CA 94544

. Sterile Processing and Distribution Technician - State of CA

Certification 2010

High School Graduate

Personal and Professional References Available Upon Request

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