Quality Assurance Manager

Rhonda P. Dobyne

Salisbury, NC *****

Phone: 404-***-**** - Email: ********@*******.***

Summary

I have several years' experience working in several manufacturing

industries within Quality, Supply Chain, and Operations; including food and

beverage, aerospace, consumer product, biotechnology (pharmaceuticals) and

chemical manufacturing environments. My experience as a manager and/or

supervisor in a manufacturing and/or office environment includes conducting

trainings, conducting and replying to audits, interviewing and hiring of

new employees, planning yearly budgets, and maintaining current permits. I

am open to relocating for the "right" position.

Qualifications

> Chemical Lab Work Experience (10+ yrs.) -- Management and Supervision

Experience (10+ yrs.)

> Chemical Research Experience (5 yrs.) -- Teaching Experience (3 yrs.)

> Instrumentation Knowledge: GC, HPLC, FTIR, ICP, Auto Titration, and many

others

> Strong Determination and Problem Solving Skills

> Advance Team Building and Communication Skills

> Program & Application Familiarity: Microsoft Office, Minitab, Mega Stat,

Stat Pac, SAP, ChemStation, LIMS, Nautilus, etc.

> Guideline Familiarity: ISO 9000, ISO 9001:2000, ISO 9001:2008, ISO 17025,

RC 14001:2008, IPEC, AS9000, AS9100, GMP, GLP, Six Sigma, NADCAP, FDA,

EPA, ASTM, USDA, and HAACP

Work Experience

Global Quality Assurance Manager

AkzoNobel (Chemical/Polymer Manufacturer) - Salisbury, NC

2012 - Present

. Ensure that proper training and development plans are in place for

analysts for laboratory testing and inspection, and routine GMP's as

appropriate. Monitors productivity in functional areas.

. Oversee the review and final approval for all raw material changes

globally including specifications, suppliers or nonconformance

. Manage 12 personnel including QC Lab Supervisor, Sr. Data Analyst,

Document Control Clerk and QC Lab Technicians.

. Responsible for system set-up and maintenance of Quality Assurance

specifications, inspection plans, certificates of analysis and

reporting in SAP.

. Serve as ISO 9001 Management Representative in accordance with the

sites Quality System and ensures compliance.

. Analyzes and investigates non-conformities, reports quality problems,

recommends corrective /preventive action, and follows-up on the

implementation and effectiveness of solutions and corrective

actions/preventive actions.

. Maintain site CAPA program which includes, HSES, Quality and

Manufacturing

. Investigate and document all technical complaints (internal and

customer) and track complaints to ensure effectiveness of corrective

actions.

. Track product history and trends using SQC analysis.

. Lead Quality improvement team meetings to review any production or

quality issues including OOS, personnel, specifications, scheduling,

raw materials, etc.

. Plans annual quality and quality assurance objectives and goals.

. Responsible for Quality Assurance aspect of Management of Change or

Significant Change Management

. Develop and maintain department budget.

. Works with the technical service and business team on specific global

quality related complaints and facilitates investigation and response.

In some cases, this will require the ability to directly and formally

communicate with the customer.

. Ensure globally, the quality management requirements and business

processes are effective with the management systems and procedures in

place.

. Coordinate/Schedule and Conduct annual internal audits based on the

ISO 9001:2008 and RC 14001 standard and periodic audits based on the

IPEC Audit Guidelines.

. Implement corrective actions to customer audit findings and ensure

closure of actions in a timely manner.

. Familiar with the Joint IPEC - PQG GMP Guide for Pharmaceutical

Excipients (2006) and/or equivalent Cosmetic GMP standards

. Conduct yearly training on IPEC GMP and/or equivalent Cosmetic GMP

standards for all site personnel

Quality Control Manager/Quality Assurance Team Leader

Stepan Company (Chemical Surfactant Manufacturer) - Winder, GA

2009 - 2011

. Direct and oversee the tactical operation of QA lab within budgetary

constraints. Provide leadership and procedures to ensure accurate and

timely reporting of quality results, adherence to customer

requirements/specifications, GMP, GLP, and ISO standards.

. Coordinate and perform statistical analysis on all method and equipment

validations

. Lead continuous improvement initiatives including creating and modifying

SOPs, serving as primary liaison with corporate R&D for all method

development and validation

. Serve as facility Process Communications and Experimental Production

Requests Administrator

. Initiated appropriate corrective actions (CAPA), RCA, FMEA and non-

conformances (NCR) and serve as Administrator for Quality Action Database

which tracked and documented all CAPAs, RCAs, FMEA, and NCRs

. Serve as SME for technical methodologies, instrumentation, product

formulations and general chemistry for all surfactant production

. Ensure product quality through the adherence to specifications, operation

strategies via SQC and established ISO 9001 system procedures and work

instructions.

. Assist in the facilitating the QA workgroups involvement in continual

improvement by evaluating processes to eliminate restricted inventory

generation.

Reason for Looking: Reduce current 4 hr. round-trip commute

Supplier Quality Manager

Biolab, Inc. - A Chemtura Company (Chemical Manufacturer) - Conyers, GA

2008 - 2010

. Documented and modified raw material specifications and finish product

SOPs as needed to support improvement of customer satisfaction and

manufacturing efficiencies including process and method development

. Identified methods of acceptance and testing for raw material (COA, SPC,

Capability, Lab testing, etc.)

. Coordinated with Packaging Engineer and Procurement to establish

packaging material specifications

. Developed incoming inspection process to identify and track supplier non-

conformities

. Initiated appropriate corrective actions (CAPA), RCA, FMEA and

improvement plans (MCO) and serve as Administrator for Quality Action

Database which tracked and documented all CAPAs, RCAs, FMEA, and MCOs

. Developed and managed supplier performance scorecard and performance

ranking that includes over 800 suppliers for more than 3000 SKUs

. Conduct supplier and internal audits to identify improvement

opportunities and initiate projects

Reason for Leaving: Company Closing due to bankruptcy

Quality Assurance Supervisor

Coca Cola Enterprises, Inc. - Montgomery, AL

2007 -- 2008

Process Development Consultant

Self-Employed - Atlanta, GA 2006 --

2008

Quality Assurance Analyst/Chemist (Contractor)

Coca-Cola Bottling Company - Atlanta, GA

2005 -- 2006

Education

University of

Phoenix

Atlanta, Georgia

Master's in Business Administration, MBA - Graduated with Honors

Purdue University

Indianapolis, Indiana

Major: Chemistry -- Minor: Mathematics

Certifications and/or Training

RABQSA ISO 9001:2008 Lead Auditor Certification (Anticipated Completion

August 2013)

Certified Six Sigma Green Belt

ASQ Cost of Quality Training and Certification

ISO 9001:2000 Certification

AS9000 Certification

ISO 9001:2008 External and Internal Auditing Certification (GAP Analysis,

FMEA, CAPA Specialist)

HAACP Training and Certification

Hazcom/Hazmat/OHSA Training and Certification

ISO 9000/Lean Manufacturing Training and Certification

Sidel Filler and Blow Mold, Pressco Administrator, and Coca-Cola Basics II

Training

Leadership Training (Effective Communication, Team Building, and Crucial

Conversations)

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