Quality Assurance Training
Resume:
Greta Brown
Stone Mountain, GA *0087 *******@*****.*** Home: 770-***-****
Cell: 404-***-****
____________________________________PROFILE__________________________________________________
¬¬¬ Highly skilled Quality Assurance Evaluator, Trainer and QA Documentation Specialist with 15 years of
progressively responsible spanning all phases of training, inspection and production, while constantly delivering
excellence in quality, training, safety and customer focus.
Ability to show initiative and commitment to the company’s goal
Ability to work effectively and efficiently in a team environment and relate well to others
Ability to readily adapt to changing requirements
Ability to communicate clearly and effectively with coworkers both in written and verbal communications
Strong commitment to performing and producing at the highest level of quality at all times
Exceptional ability to handle multiple tasks and conduct with accuracy and a high attention to detail
____________________________________EXPERTISE________________________________________________
QA Training: Effectively facilitate training courses, job aids and reference manuals to meet the develop-
mental objectives of various audiences in an effort to drive process improvements, standard
methods, and competencies.
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 (Introduction)
____________________________________EXPERIENCE______________________________________________
REMINGTON MEDICAL, INC. Alpharetta, GA. Oct. 2011 – Present
QA/QC Associate
Process manufactured in-process and final product through a series of tests to verify that product meets
all documented specifications.
Authorize the release of product for production use or delivery to customers
Complete related paperwork and data entry to support inspection procedures
Lead, organize and manage quality inspection workflow
Initiate NCRs, document change notices(DCN) and other quality documents in support of daily process
Ensure GMP conformity for raw materials and components disposals
Process return goods for disposition and destruction
MEDA CONSUMER HEALTHCARE, Marietta, GA. Apr. 2011- Jun. 2011
(Formerly Alaven Consumer HealthCare, Inc.)
ALAVEN CONSUMER HEALTHCARE, INC. Marietta, GA.
QA Associate 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.
Collaborated closely with CSR’s to re-create customer problems as necessary during investigation
Evaluated complaints to analyze whether an investigation is necessary
Analyzed complaint data monthly to identify new and systemic issues as necessary
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
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
Delivered initial training to new and existing employees using various materials in addition to visual aids
Created and implemented training manuals for employee use during training and annual recertification
Monitored and coached new and existing employees on job performance issues
Conducted internal audits on new trainees to evaluate training process effectiveness
Designed user-friendly test material for all employees for the purpose of certification
Assigned to Singapore for initial training of all employees for startup of new manufacturing facility
Served on a project team that converted written documents from SOP’s to picture process map (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.
Collaborated with technicians and support departments to complete complaint analysis and compile investigation results
Prepared responses to complaints as necessary per process
Reviewed and assessed deviations, including evaluation, tracking, follow-up, and trending
Reviewed SOPs, batch records and test techniques prior to final release of product
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
Worked closely with engineers in collecting production samples for pre-test and post-test
prior to validation of equipment.
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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