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Customer Service Quality Assurance

Location:
Lithonia, GA, 30038
Posted:
August 29, 2016

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Resume:

MYRA GODETH

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

Lithonia, Georgia 30038

Cell 404-***-****

acwd28@r.postjobfree.com

MANUFACTURING ENGINEER

Six Sigma / Process Improvement / Lean Manufacturing

Six Sigma Black Belt with 10+ years of experience in quality engineering, QA/QC, pharmaceutical, medical device and chemical manufacturing; excellent customer service, problem solving, leadership and communication skills. Delivering and improving product quality procedures and processes ensuring compliance to ISO, FDA, cGMP, QSR and OSHA regulatory requirements.

AREA OF EXPERTISE

• Quality Assurance leadership

• Statistical Analysis

• Quality Management System

• Statistical Process Control

• Process and Performance Capability

• Compliance documentation

• Root Cause Analysis

• Continuous Improvement

• Customer Complaint investigation and

reviews.

• Quality tools (FMEA, Process Mapping,

Pareto Charts, Control Plan, Fishbone

Diagrams, 8D Corrective Action Reports,

5S Implementation Six Sigma DMAIC Project

• Internal/External Quality Auditing

• PPAP reports and submission

• Measurement System Analysis

• Qualitative and Quantitative Analysis

• MS, Word, Excel, Outlook, Power Point,

Visio and Minitab.

PROFESSIONAL EXPERIENCE

Quality Engineer/Lab Manager, Plastics Peachtree City, Georgia

M. A. Industries, Inc. 2015–2015

Increased and improved Quality Assurance Lab productivity by 30%.

Investigated and resolved quality issues in three divisions, (molding, porous plastics and paper).

Performed detailed analysis of returned and used findings to drive CAPA improvements.

Generated spreadsheet to verify and track Customer Complaints and minimized closing inside target date.

Improved and reorganized ISO 9001 Quality Management System companywide.

Minimized quality issues in shipping (checklist implementation) by working with team.

Reduced line item defects by working with the customer service team to develop a new product order request form to effectively captured required information.

Produced AIAG PPAP and weekly progress reports; prepared MSA studies, PFMEA, process flow diagram and control plan, SPC and process and performance capability summary reports, Work Instructions, Quality Alerts, 8D CAR, supplier/customer audits, deviation reports and conducted internal auditing.

Gained experience reading customer specification drawing and preparing ECR/ECN documentation process.

Contributed to the Balanced Scorecard monthly meetings.

MYRA GODETH

PROFESSIONAL EXPERIENCE

QA Analyst II / Beverage Base Atlanta, Georgia

Coca Cola Company 2014 – 2014

Achieved compliance to GMP, GLP, ISO17025, Food Safety ISO 22000 and ISO 9000 standards and Quality Assurance requirements by performing wet chemical analysis and instrumental methods to determine the composition of samples.

Contributed to communication with production staff to investigate and resolve the product non-conformance issues ensuring internal/external customer specifications.

Generated documented data results and monitored Statistical Process Control (SPC). Trained other contractor personnel; prepared for internal/external audits.

QC Chemist III / Contract Pharmaceutical Atlanta, Georgia

Mikart, Inc. 2013 – 2013

Generated instrumental and wet chemistry analysis of raw materials, in process, final and stability on solid and liquid dose pharmaceuticals.

Achieved completion of Laboratory projects in accordance with Mikart’s specifications and analytical testing procedures and adherence to FDA, USP, and cGMP guidelines.

Contributed to reconciling all controlled drugs schedule II and schedule III in accordance with DEA regulations.

Manager Lithonia, Georgia

The Fragrance Center/Stonecrest Mall 2011 – 2012

Promoted a team environment to increase productivity and motivate the staff exceed daily sales quotas.

Minimized scheduling, shift change, training, inventory control conflict and issues.

Production Scientist/Medical Device Cincinnati, Ohio

Meridian Bioscience, Inc. 2008 – 2010

Produced clinical diagnostic test kits and purified reagents for infectious disease adhering to FDA, GMP, SOP, QSR, and ISO13485 guidelines to meet manufacturing and customer specifications.

Improved customer complaints resolution by working with Investigation Scientist and Validation Engineer on projects to reduced manufacturing non-conformance issues to meet customer’s specification.

Generated Out of Specification and deviation reports, Root Cause Analysis and CAPA for quality assurance review and closure.

Gained solid experience in batch formulation, statistical techniques (trending analysis), data management system reports, technical writing, controlled documentation, peer review and compliance auditing.

Analytical QC Chemist/Packaging Operator Cincinnati, Ohio

Forest Pharmaceuticals, Inc. 2001– 2007

Produced prescription drugs for stability and release testing utilizing USP/NF standards test methods complying with strict FDA, OSHA, cGMP regulations.

Contributed and executed analytical and instrumental techniques to analyze raw materials, in-process and finish products; performed validation studies and prepared for lab audits.

Performed packaging quality inspection, in process quality check, QA hold, rework and rejection, material destruction process in adherence to SOPs and quality assurance guidelines.

Reduced machine downtime by troubleshooting and problem-solving technical and mechanical challenges.

MYRA GODETH

PAST EXPERIENCE

Analytical Chemist/ R&D, HCRC Mason, Ohio

Procter & Gamble 1999 – 2000

Analytical Chemist/Regulatory, Raw Materials Cincinnati, Ohio

Givaudan Roure 1997 – 1999

Laboratory Technician QC/ Wet Chemistry Cincinnati, Ohio

Henkel Corp. Chemical Group 1997

Laboratory Technician QC/ Wet Chemistry Cincinnati, Ohio

W.R. Grace & Co. 1996 – 1997

EDUCATION

Lean Six Sigma Black Belt Certification, July 31, 2016

Lean Six Sigma Black Belt Program, December 5, 2014

Lean Six Sigma Green Belt Certification, July 11, 2014

J. Mack Robinson College of Business

Georgia State University, Atlanta, Georgia

Bachelor of Science Biology/ Chemistry, 1987

Xavier University, Cincinnati, Ohio

AFFILATIONS

ASQ-Atlanta Chapter (Section 1502) Member ---February 2015-Present

Operational Excellence- local Atlanta Chapter Member August 2014- Present

Toastmasters Mentor 2007-2011

Toastmasters Area Governor 2008-2009

Toastmasters Club President 2007- 2008

Toastmasters Vice President Education 2006-2007

Myra Godeth

5777 Winchester Place

Lithonia, Georgia 30038

August 29, 2016

Dear Sir/Madam:

As a dedicated professional with excellent liaison, research, technical and customer service skills. To continue my career transition, I am interested in the Manufacturing Engineer position to contribute my energy, my skills and my experience.

While my attached resume will provide you with a general outline of my abilities and work history, I have listed my applicable skills relevant to your current needs. I hope this will enable you to use your time effectively.

Bachelor of Science Degree

Lean Six Sigma Certification.

An individual who is efficient and self-motivated.

Project Management experience with ability to effectively communicate across multiple

departments and personalities.

Technical understanding of raw materials, in-process and finish products used to manufacture consumer goods; with ability to compile, to interpret and to present data.

Ability to effectively plan, to organize, and set priorities to meet critical deadlines in a safe working environment; dedicated to customer service; willing to travel extensively.

Strong sense of accountability, diplomatic, decisive and committed to professionalism.

My resume is enclosed. I am confident my skills would be of use to you right away in this new position. I request a few minutes of your time to discuss my qualifications. If you have any questions in the meantime, please feel free to contact me at 404-***-**** or e-mail acwd28@r.postjobfree.com.

Sincerely yours,

Myra Godeth

Enclosure: Resume



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