Quality Assurance

Tamika M. Parrish

310-***-****

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

Objective

To obtain a challenging position which utilizes my skills in Quality

Engineering while embarking on the opportunity to enhance and contribute to

the goals and success of this company.

Education

9/2002 - 6/2005 Rutgers University, New Brunswick, New Jersey

Master of Science (M.S.) in Biomedical Engineering

9/1997 - 6/2002 Kettering University Flint, Michigan

Bachelor of Science (B.S.) in Mechanical Engineering

Professional Summary

. Over 6 years of experience in FDA, ISO 13485 and international

regulated medical device and healthcare industries.

. Able to manage multiple projects and product lines simultaneously

and effectively.

. Proficient in writing technical documents such as GMP Quality

Record forms, SOPs, Validation Protocols and others.

. Self-starter, highly motivated, ready to undertake assignment with

positive attitude and provide great contribution.

Experience

June 2012-July 2013 American Neuropsychiatric Research Institute, Inc,

Carson, CA Clinical Research Coordinator

. Trained in ICH GCP principles and practices

. Lead Phase 2 & Phase 3 Outpatient Pharmaceutical Clinical Trials

. Work directly with psychiatrists in the conduct of various clinical drug

trials

. Maintain accurate patient records on all clinical trials, screening of

patients, study drug accountability, taking patient vitals, scheduling

appointments, processing labs and shipments, entering source data into

electronic CRFs, and monitoring the progress of the patients for physical

and psychological changes and medication compliance

. Report Study Adverse events and Protocol violations to appropriate IRB

and Pharmaceutical Companies

. Maintain all source documentation and regulatory documentation as

required by the FDA

October 2006 - January 2011 One Lambda, Canoga Park, California Quality

Assurance Engineer

. New Product Development (NPD) Quality Assurance representative,

collaborated with cross-functional department managers to release

new products to the market

. Analyzed volume accuracy of automated dispensing system using

Minitab Statistical Software

. Managed Accelerated and Real-time product shelf-life extension

studies

. Initiated, managed and closed Product and Manufacturing Process

Change Requests

. Created and released Device Master Record (DMR) SOPs for new

products

. Assisted with FDA and TUV audits, gathered appropriate validation

data, reports and production Quality Records

. Responsible for maintaining the DMR electronic documentation system

ensuring that all product line processes and materials required

were accurate and effective

. Assisted in the implementation of an electronic DMR Quality

Management System

. Assisted in CAPA plans and resolving field performance issues

. Enforced the completion of vendor audits to ensure compliance with

GMP practices

. Created and maintained company database of all incoming raw

materials

. Project leader for identifying and validating secondary suppliers

of raw materials

. Assisted in the hiring and training of new Quality Engineers

. Provided weekly, monthly and yearly quality reports identifying the

status of open projects and recently closed projects and identified

areas of continuous improvement

October 2005 - September 2006 Boeing SDC, El Segundo, California Quality

Assurance Engineer (Contractor)

. Identified and tracked manufacturing, design and system test

anomalies

. Managed non-conformances and issued proper disposition

. Responsible for monitoring system test surveillances

. Worked on the manufacturing floor and collaborated with the

Production Control, Planning and Engineering departments to meet

pre-determined build schedules

. Presented weekly quality report to management

October 2004 - July 2005 Medtronic, Inc, Columbia Heights, Minnesota

Mechanical Design Engineer

. Drafted validation test plans and reports

. Collected and analyzed test data

. Participated in product design and manufacturing capability of

implantable diabetic insulin pump

. Provided technical support to 3-D computer draft design team and

product development lab technicians

. Designed test fixtures to evaluate prototype components

. Team leader in the evaluation of body gas permeation through

biodegradable polymers

. Evaluated biodegradable polymer and insulin compatibility

Specialized Training

Good Manufacturing and Laboratory Practices, Kaizen Continuous Improvement

Process, 5S Workplace Methodology, Minitab, MS Word, Excel, PowerPoint,

Outlook

Contact this candidate