**** * ******** ***** ***** 479-***-****

Fayetteville, AR 72701 E-mail: abhmob@r.postjobfree.com

Laura Williams

Manufacturing Management position which will utilize my prior experience and skills in

Objective

quality operations, lean management, manufacturing and engineering to increase

productivity and profitability of the company.

Summary of Rockline Industries Springdale, AR

Quality Assurance Manager

qualifications

Responsible for all plant quality including vendors, customers, process

improvement, internal auditing and process improvement.

Assist in the selection of suppliers as well as supplier performance reviews.

• Develop and adhere to fiscal budget.

• Member of the senior management team for the facility; involved in making plant

wide decisions.

• Develop / Determine key performance indicators for the facility related to quality

• Provide key performance indicator data report outs to multiple departments within

the plant

• Coordinate and provide quality training for the facility.

• Responsible for all internal audits by customers as well as third parties.

Responsible for strategic plan of the Quality department

Responsible for continuous improvement within the quality organization.

Communicate with customers on a regular basis to investigate any concerns or

quality issues.

Handle both internal and external CAPAs

Responsible for the development and management process control including good

run settings for equipment and SPC.

• Meet customer requirements set forth in product specifications as well as quality

agreements.

• Lead multiple cross functional teams to complete Quality objectives.

• Supervise a staff of 18 (includes supervisors, technicians and engineers)

• Responsible for developing staff based on their career goals as well as succession

planning.

Interact / communicate with all levels throughout organization.

Global Supplier Quality Manager

Responsible for qualifying, auditing and evaluating all suppliers for Rockline globally.

Provide support and guidance to new suppliers / Rockline facilities to become

compliant to various regulatory standards (FDA part 210-211, FDA part 820, ISO 13485,

ISO 9000, Health Canada, EPA, etc).

• Develop the foundation of the Supplier Quality Management Program.

• Work with all facilities, Purchasing and suppliers to resolve key quality issues

throughout Rockline.

Responsible for the development and management of the global supplier audit plan.

• Coordinate test methods and sampling plans with suppliers to ensure that

purchased materials meet Rockline requirements.

Quality responsibility for contract manufacturers used by Metrex.

Interact / communicate with all levels throughout organization.

Baxter Healthcare Mountain Home, AR

Various positions

13 years of experience in a pharmaceutical manufacturing facility (including both drugs and

medical devices).

Quality / Process engineering experience from 2001 – 2007.

Lead validation projects and process changes on major equipment throughout the

manufacturing environment. Examples include: implementation of new test methods to

decrease release times, software validation to decrease release times of manufacturing

batches, qualification of new materials for production, qualification of new manufacturing

parameters.

Experienced in both equipment and process validations.

Generated protocol studies and performed statistical evaluation of data when required.

Led FMEA (failure mode effects analysis) teams as part of validation studies.

Participation in Kaizen and lean events in the facility.

Practiced continuous improvement principles utilizing SPC / Six Sigma in validation /

qualification studies.

Plant lead for corporate projects. Responsible for executing corporate studies / evaluations,

reporting results, meeting target dates, product launch dates, etc. Interface daily with

corporate regarding these studies in addition to plant responsibilities.

Lead cross functional teams including maintenance, project engineering, software

engineering, quality engineering, quality control, manufacturing, purchasing, scheduling,

receiving / inspection, laboratories, critical systems, etc, depending upon the specific project.

Manufacturing experience in polymer blending / extrusion, injection molding, finished goods

(medical devices) and needle production (grinding and polishing processes).

Two years of experience in production planning, developing production schedules, working

with customers to meet ship dates, ensuring on time delivery of product.

Excellent understanding of regulatory requirements.

Involved in plant audits by corporate and outside regulating bodies i.e. FDA, TUV, OSHA,

ISO, etc

Managed a staff of ten - fifteen personnel including hourly technicians and administrative

employees.

Responsible for developing and adhering to budgets ranging from $500,000 to $1,000,000.

In charge of hiring, conducting performance reviews and providing disciplinary action of

personnel when needed.

Experienced in working with all levels of operation from hourly employees to corporate

directors and VPs.

Excellent communication skills, both written and oral.

Experienced in CAPA – corrective and preventive action

Vast experience in complaint handling / resolution.

Excel at organizational, time-management and multi-tasking skills

Customer focused.

Excellent ability to grasp and explain complex scientific information.

Great trouble shooting / problem solving skills / always try to find the solution

Understand the importance of teamwork and communication

Supervisor since 1997

Years of experience with cGMP

Experience in internal facility audits as well as external supplier audits

Instrumental in supplier certification / vendor qualification efforts

Utilized chemical background for material review and selection in the manufacturing

environment

Experience with document control

Participated in quality reviews identifying key indicators to determine level of performance

Managed a complex Chemistry lab; backup supervisor for Microbiology lab.

Employment Aug 10 - Current Rockline Industries Springdale, AR

Quality Assurance Manager

Mar 09- Aug 10 Rockline Industries Springdale, AR

Global Supplier Quality Manager

Aug 08- Feb 09 Rockline Industries Springdale, AR

Quality Support Manager

May 08-July 08 Washington Regional Fayetteville, AR

Registered Nurse

Mar 08 – May 2008 The Right Solutions Tontitown, AR

Nurse Recruiter

Feb 2008 –Mar 2008 Northwest Health Springdale, AR

Registered Nurse

Jul-2007 –Feb 2008 Vista Health Fayetteville, AR

Registered Nurse

2001-2007 Baxter Healthcare Mountain Home, AR

Sr. Quality / Process Engineer / Quality Section Supervisor (contract position from 2005 - 2007)

1999-2001 Baxter Healthcare Mountain Home, AR

Sr. Production Planner / Customer Sales

1997-1999 Baxter Healthcare Mountain Home, AR

Chemistry Lab Supervisor

1994-1997 Baxter Healthcare Mountain Home, AR

Chemist / Chemist II

Education 1989 - 1994 Southwest Missouri State Springfield, MO

Chemistry / Biology minor, cum laude, GPA 3.52

2005-2007 Missouri State University West Plains, MO

Nursing, GPA 4.0

Additional Proficient in Word, Excel, Powerpoint, AS400, JDE, Infinity QS, Statgraphics and Minitab

Familiar with various types of packaging, injection molding, plastic extrusion

Experience in pharmaceuticals, medical devices, healthcare, consumer goods

Contact this candidate