Quality Assurance Customer Service

Lenita Jean Onen

*** ****** ***** **.

Lilburn, GA 30047

Cell: 770-***-****

Email: *******@***.***

OBJECTIVE: To obtain a position that is challenging and rewarding.

EMPLOYMENT HISTORY

FACET TECHNOLOGIES 2010 - 2011

QUALITY ASSURANCE

• Represented department in cross-functional teams, projects and GXP related problem resolution.

• Performed Documentation Review for Product Release

• Receiving raw materials & Document review

• Managed consistency in work throughput

• Assisted with Supplier Related Complaints and Investigations

• Ensured compliance with cGMP, ISO/FDA and company Regulations

• Provided necessary support & assistance in training activities

• Organized, designed, and implemented comprehensive on-the-job training activities.

• Collected and organized tests/inspections of products, services or processes to evaluate quality of performance

CIBA VISION 1992 - 2009

Technician

• Operated automation machines producing contact lenses

• Inspected quality of contact lenses for various defects

• Utilized microscope to determine center thickness of molds

• Performed radius and cylinder measurements in lab

• Reviewed and approved GMP Controlled Documents, SOPs, and Batch Records.

• Data entry on production numbers, quality assurance, and machine malfunctions

• Collected samples and sent to Laboratory

• Represented departments in cross-functional teams, and projects

• Performed Batch Record preparation, issuance, and Batch Record reviews

• Ensured full GMP compliance for the disposition of Raw Materials and Components

• Performed Statistical Process control and inspections

• Final Product Inspection

• Processed customer complaints and returns

SKILLS/ABILITIES

• Customer Service

• Quality Assurance

• Lab practice and procedures

• Machine Automation

• Data Entry

• GMP/ISO 9000

• Clean Room Environment

EDUCATION

Everest Institute, Norcross, GA 2/09-9/09

Medical Administrative Assistant

Gwinnett Tech, Lawrenceville, GA 1984-1986

Nursing

AWARDS

Directors Honor Roll

Perfect Attendance

References Available Upon Request

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