Quality Assurance Customer Service

Clara M. Walker Home 317-***-**** Cell 317-***-****

OBJECTIVE

To obtain a position as a leader in Quality with a company offering exposure to leading edge technologies and

promoting further career advancement. A Quality Assurance leader with a proven track record of strategic quality

assurance vision, quick delivery, and demonstrated ability needed to inspire/mentor teams to implement the latest

technology for exceeding industrial quality standards. Enthusiastic team player with strong work ethics and advanced

complex problem solving skills, bringing management experience and a willingness to take on additional

responsibilities to meet tight deadlines extremely results oriented and proactive addressing and resolving problems in

timely manner.

EDUCATION

Associate Degree of Science: Medical Laboratory Technology Indiana Vocational Tech College- Indianapolis,

Indiana May 1984 Vice President of Student Affairs.

Additional Courses: Nursing, Indiana University Purdue University Indianapolis- Indianapolis, Indiana

High School Diploma: Emmerich Manual High School – Indianapolis, Indiana June 1980

Majors: English, Math, Biology Top 10% of class, National Honors Society.

Skills: Exceptional Interpersonal Communication, Effective Leader, Staff Training/Development, Employee

Scheduling, Consistently meet goals, Efficient multi-tasker, Project Management, Conflict Resolution,

Customer Service-Oriented, Organized, Deadline-Oriented, Depth OSHA and FDA knowledge, Corrective

Acton Preventative Action Power User, Procedure Writer and Extremely Quick Learner.

WORK HISTORY

Quality Assurance Manager New Sunshine Manufacturing Indianapolis, Indiana

March 2012-January 2013

1Plan, develop and coordinate quality assurance procedures for the manufacture of skin care products consistent

with established standards.

2Continued education to maintain working knowledge of government and industry quality codes and standards,

educated staff on GMP's and FDA regulations.

3Manage customer complaints, corrective and preventative actions, quality requests, complete reports regarding

non-conformance of products and processes, daily production quality and root cause analysis.

4Manage and guide quality, manufacturing and production staff by formulating, monitoring, directing and training

staff on 47 procedures, processes and policies.

5Developed and maintain all Official Laboratory Data Documentation records.

6Conduct periodic quality checks and audit vendors and authored evaluations.

7Conducts quality checks on incoming raw materials to established standards.

8Develop product specifications, establish material safety data sheets, certificate of analysis, certificate of

ingredients, and completed certificate of testing for each product.

9Identified critical points in manufacturing process, developed sampling procedures to be used at these points.

10Applies communication skills and ability to interact effectively with all employees, peers and executives.

11Utilize strong project management and computer skills including Axapta, Word, Excel, CAPA and PowerPoint

to achieve successful launch of 60 new products for 2013 while maintaining 2012 products.

12Lead employees by coaching, leading by example and driving positive behavior, processes and culture changes.

13Educated Research & Development employees for successful relationship and method transfer to quality.

14Safety compliance officer and employee and college recruiter for Company.

Senior Chemist Eli Lilly and Company PMQC (Raw Material Testing), Indianapolis, IN

Feb1988- May 2011

1Lab leader to ensure lab is operating 5S efficiently and compliant. Conducts weekly cGMP’s lab audits.

2Lab representative for FDA and all regulatory inspections answering questions, back room support and providing

requested documents.

3Lead Corporate College Recruitment Team.

4Subject matter expert for Standard Operating Procedures and Equipment Operating Procedures develops, writes,

validates, and transfers analytical methods.

5Performs miscellaneous tasks that rises to allow the lab to comply with federal regulations, ensures inspections

readiness at all times.

6Authoring change controls, protocols and executing method verification and validations.

7Second person verifies all processes and data according to GMPs, GLPs, SOPs and EOPs.

8Technical writing including compilation and submission of departmental Periodic Quality Evaluation documents.

9Conduct material characterization and qualitative testing for raw materials according to ACS, USP, PhEur and JP

methods.

10Lead Lean Six Sigma project leader for eliminating non-value added testing.

11Assist cleaning validation group, work with statistician to determine the number of samples needed, schedules

testing with labs, writing and verifying cleaning validation protocols, pull samples and completes testing.

12Contact person for FDA and Lilly Corporate Quality Assurance inspections.

13Schedule all testing, manage vacation schedules, and perform routine lab audits.

14Authored white paper for particulate testing industry worldwide.

15Complete Performance Management Plans and provided performance feedback and development direction for

each analyst.

16Member of the Self Inspection Auditing Team, which included oral and written presentations of routine lab

audits.

17Member of the divisional hiring team which included: screening resumes from HR, initial phone screen

interviews, setting up personal interview list, making travel arrangements and hosting new associates upon

arrival extending hospitality, making reservations, attending dinner and information sharing session.

COMPUTER EXPERIENCE:

Microsoft Office (Word, Excel, Access, PowerPoint), Windows,

ADMIN/LIMS and SAP, Track Wise-CAPA, GLIMS (Darwin LIMS), Lotus Notes and Axapta.

Technical Skills & Lab Instrumentation:

Extensive experience with the following programs and instruments:

Karl Fischer Coulometric and Volumetric analysis, FTIR, UV/VIS Spectrophotometer, HPLC/GC/ICP/IC Analysis,

HIAC, Microscope, Wet Chemistry Analysis, TLC, FRCC and JMP. CAPA, Sterility Testing, Cleanroom Techniques,

Media Preparation, Particulate Testing, Targeted Selection, Empowering a Diverse Workforce, Violence in the

Workplace, Management Health & Safety, Sympatec training, FTIR and McCrones Research Institute Small Particles

Identification, Technical writing, Insights Into Personal Effect and CAPA Lead Investigator, Self Inspection Team,

Crucial Conversations, Now Discover Your Strengths, Situational Leadership I and II.

REFERENCES

Available upon request

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