Quality Assurance Customer Service

Greta Brown

**** ******* **

Stone Mountain, GA *0087 *******@*****.***

Home: 770-***-****

Cell: 404-***-****

PROFILE

GRETA

BROWN

Highly skilled Quality Assurance Evaluator and QA Documentation

Specialist with 15 years of progressively

responsible spanning all phases of training, inspection and production,

while constantly delivering excellence in

quality, safety and customer focus.

. Strong leader, with demonstrated ability to perform independently or

as an effective team player.

. Proven ability to assimilate, implement, and to instruct others in new

skills and processes.

. Attentive commitment to accuracy, detail, and quality performance.

EXPERTISE

QA Training: Developing and delivering initial training prior to

certification, revising procedures, following up

on corrective actions, and participating in

internal audits.

QA Evaluating: Overseeing operations ensuring compliance with all

cGMP, FDA, OSHA, ISO standards and

internal procedures: inspecting finished

/packaged goods, and evaluating documentation.

Software: Word, Excel, Lotus Notes, Power point, Access,

Track Wise

EXPERIENCE

UCB, INC. Smyrna,

GA, Apr. 2012 -

Present

Product Complaint Associate

. Monitor incoming complaints to ensure that potential adverse events

have previously been identified and forwarded to Drug Safety.

. Manage incoming product technical and distribution-related complaints

in collaboration with Medical Information through triage,

documentation and proper routing of complaint information for

investigation

. Receive, review and maintain the results of technical complaint

investigations to ensure that all product complaint investigations are

appropriately investigated and concluded

. Communicate appropriate complaint data and instances to management as

needed.

. Responsible for complaints trend analysis, risk analysis activities,

writing respective reports and presenting complaint data to management

as required.

REMINGTON MEDICAL, INC.

Alpharetta, GA. Oct. 2011 - Apr. 2012

QA/QC Associate

. Inspect incoming materials used to manufacture, solder, assemble,mold, sterilize and test

RMI and OEM products and their components

. In-process inspection for cleanroom and boxing of finished goods prior

to release

. Assist with endotoxin screening and coordination of product testing

. Initiate NCRs, document change notices(DCN) and other quality

documents in support of daily process

. Returned goods authorization( RGA) disposition and destruction

. Workorder review and release

MEDA CONSUMER HEALTHCARE,

Marietta, GA. Apr. 2011- Jun. 2011

(Formerly Alaven Consumer

HealthCare, Inc.)

ALAVEN CONSUMER HEALTHCARE, INC.

Marietta, GA.

QA Associate(Contract)

Jan. 2010 -

Aug. 2010

. Assist in generation, revision, and review of SOPs and quality

documentation.

. Archival, organization, and maintenance of Quality and Regulatory

Affairs documentation.

. Finished product releases, component releases, disposition of returned

products at warehouse

. Review of returns and complaint forms from ACH Customer Service to

screen quality related complaints

. Create database for processing, forwarding, trending and reconciling

complaint investigations for CAPA

. Revise labeling as requested by Marketing or Regulatory and accuracy

check of labeling

. Assist in review of batch records, change control records, deviations,

and analytical test results

. Assist in training personnel on cGMP, SOPs, or other relevant training

. Request and maintain quality documents from contractors as necessary

CIBA

VISION, Duluth, GA 1993-

2009

MQA Inspector

2008-2009

. Investigated product and process nonconformance's for root causes.

Identified and implemented

corrective and preventive actions to improve compliance, product

quality and efficiency.

. Performed product release to Finished Products according to

departmental procedures.

. Inspected in-process products and components ensuring product

specification.

. Interacted with multiple departments guaranteeing compliance with FDA,

cGMP, OSHA and ISO.

Training Coordinator

2001-

2008

. Designed, developed and delivered training using such material

in addition to other reference works and

Visual aids.

. Reassigned to Singapore for six months to deliver extensive lens

inspection training.

. In charge of new hires on boarding to include orientation, assigning

badges, time-keeping, safety training and proper use of equipment.

. Effectively, delivered recertification training to all lens

inspectors, (approximately 165 employees), that resulted in overall

quality improvement from 85% to 93% within a calendar year.

. Developed Standard Operating Procedures to comply with FDA

regulations.

. Served on a project team that converted written documents from SOP's

to picture process maps. (PPM)

. Maintained SOP's and Training Master Records for continuous process

improvement.

Quality Coordinator

2000-

2001

. Investigated customer complaints by utilizing the Quartz System in

addressing all complaints.

. Implemented a user friendly tracking system for all nonconforming

reports (NCR) within a timely manner.

. Conducted monthly operational audits to evaluate each inspector's

ability to properly identify defects.

. Assisted in implementing new and revised documents (SOP's) for

specific departments.

. Contributed to the development of a quality management system by

writing procedures and implementing

an official quality manual.

CIBA VISION,

Duluth, GA.

Validation Auditor

1998-

2000

. Tested various station on linear table (equipment) by sampling product to

determine if each

station was functioning properly prior to validation approval.

Distribution Operator

1997-

1998

. Picked, packed and sorted orders by use of a RF Scanner prior to

distribution.

Technician Trainee

1993-

1997

. In charge of production lab in absence of the lead technician.

Responsibilities included

* Assigning F.A.'s (Flow Authorizations) to each inspector for RX

Measurements

* Reviewing and closing out batch records.

* Initiating NCR's for any out of specification F.A.'s.

Quality Inspector

. Provided quality assurance and inspection of product produced by line

staff. Conducted various tests on

lenses for

* Cosmetic Inspection - using a Shadowgraph

(Optispec)

* Rx Measurement- using a Marco/Nikon

* Center Thickness Measurement- using a Rehder Gauge

EDUCATION

Psychology ABRAHAM BALDWIN AGRICULTURE COLLEGE, Tifton, GA.

One year completed

Stenography BROWN COLLEGE OF COURT REPORTING, Atlanta, GA.

Four years completed

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