Quality Engineer

Amy Baremore, MBA

*** ******** ** *********** ** 65742 Cell: 417-***-**** E-mail:

abhlfq@r.postjobfree.com

Results oriented, highly motivated leader with strong people and

negotiation skills seeking a challenging pharmaceutical sales position.

Profile

. 16 years of pharmaceutical/biotechnology experience with 6 years of

progressive business management experience.

. Highly motivated self starter able to manage multiple priorities.

. Creative and persistent: skilled at developing long term relationships

by listening with empathy and anticipating their needs.

. Quick learner: ability to learn technical information and adapt easily

to new situations.

. Dedicated, energetic professional with a strong work ethic.

. Confident with new technology.

. Skilled negotiator with strong problem solving skills.

. Effective team player with outstanding interpersonal and presentation

skills.

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Natural Cheese Business Unit Leader - Kraft Foods - Springfield, MO March

2010 to Present

. Direct and manage business unit resources for the Springfield Natural

Cheese division to successfully deliver results in quality, cost,

safety, service, and employee morale.

. Leader in the design and implementation of company Cost Improvement

Projects through optimizing and increasing the efficiency of the

Manufacturing process, equipment and labor utilization, delivering 1.86

MM in cost savings in 2010.

. Led project team to reduce Consumer Complaints by 40%.

. Monitored, tracked and identified production gaps in order to drive

operating efficiency improvements and bring the department back into

the green.

. Lead by example driving safety improvements, aggressively working to

reduce the 2010 department Safety Recordable rate vs. 2009 and

improving the rate from 13.5 when joining the department to 3.94.

. Created and implemented a new forecasting tool allowing the department

to realistically establish case counts, identify choke points on a

product by product basis and predict cost while tracking variances real

time.

. Received manager's award in recognition of the Shred Packaging and

Quality improvements.

. Address personnel issues head on, establishing clear goals and

expectations resulting in improved department performance and employee

morale.

. Develop high performing work teams to effectively meet the changing

needs of the business.

. Responsible for supervision of 240+ employees in a 3 shift high-speed

production setting.

Senior Quality Systems Supervisor - Kraft Foods -Springfield, MO

August 2009-March 2010

. Provided leadership and technical assistance to Operations by

aggressively managing quality control systems, instilling quality

awareness and commitment and performing fact based assessments of

manufacturing operations to assure Kraft's position as the leading

producer of products which provide superior consumer satisfaction and

value in an efficient, cost effective manner.

. Provided technical expertise to the Manufacturing Operation in food

science, microbiology, chemistry, statistics, and good manufacturing

practices by identifying process variation and implementing innovative

technology in order to establish and initiate the best manufacturing

methods with the goal of producing uniform products in compliance with

company specifications.

. Assisted in training by providing statistical techniques, quality

awareness, and GMP's to improve product knowledge, to ensure product

consistency and process efficiency.

. Assured timely implementation of new and revised products and processes

by reviewing proposed instructions, organizing need testing, analyzing

output, and supplying feedback to provide desired product while meeting

quality, manufacturing efficiency, and cost parameters.

. Naturals liaison for all Quality, Food Safety, and Regulatory

Compliance operating under FDA, and Kraft regulation.

Quality Assurance Manager- Genentech- Biopharmaceuticals- Oceanside, CA

Dec 2007- August 2009

. Full responsibility for all facets of quality systems at a facility of

700+ employees.

. Acted as liaison for all regulatory inspections including FDA, Japan,

China and Europe.

. Actively led 6 sigma projects and Lean initiatives for both Quality and

the plant resulting in the Oceanside facility being the first site to

achieve "Class A" recognition by Oliver Wight as a World Class/Lean

Manufacturer.

. Ensured adherence to and compliance with established company quality

policies, practices, and federal regulations.

. Ensured quality of materials purchased, processed, manufactured and/or

distributed.

. Led investigations to resolve potential product quality issues and to

improve efficiency.

. Managed performance and development of direct reports to ensure

achievement of organizational and department goals.

Sr. Site Compliance Manager- Genentech- Biopharmaceuticals- Vacaville, CA

May 2005 - Dec 2007

. Managed GMP Compliance program for site in Vacaville, CA and Porrino,

Spain, providing consultation and guidance to facilitate the resolution

of site and global compliance issues.

. Developed and implemented Site Representative Program for GMP

Compliance.

. Coordinated, planned and executed GMP audits at Genentech's

manufacturing and contract manufacturing sites to assure compliance

with applicable FDA and international regulatory requirements.

. Managed group of internal and external auditors

Senior Validation Engineer - Genentech- Biopharmaceuticals-Vacaville, CA

Aug 2003 - May 2005

Porrino, Spain

Mar 2002- Aug 2003

San Francisco, CA Apr 2001-Mar 2002

. Successful implementation and on time start-up of a new

Biopharmaceutical facility in Spain.

. Responsible for providing Quality strategy, planning, technical

expertise, and task leadership.

. Performed validation of biochemical manufacturing, filling, packaging,

equipment, utility and automation systems and processes.

. Provided technical assessment and review/approval of Validation

protocols/summary reports and Engineering, Automation and controlled

document changes.

. Presented during regulatory inspections

. Managed the activities of junior validation personnel and contractors.

Quality Engineer - Alpharma - Pharmaceuticals -Lincolnton, NC

Mar 2000-Mar2001

. Responsible for validation of bulk, filling and packaging equipment,

utilities and automation systems.

. Developed site and Corporate Quality Policies and Master Plans for

cleaning, facilities and equipment validation.

. Monitored the performance of production processes by analyzing and

trending manufacturing data.

. Managed the validation of a new manufacturing area.

. Performed process validations and investigations.

. Performed a Corporate Quality Engineering assessment and provided

remediation support.

Foundational Career Experience

Chemist - Abbott Laboratories - Hutchinson, KS

Mar 1996-Sept 1997

Validation Engineer - Abbott Laboratories - Hutchinson, KS

Sept 1997-Dec 1999

Documentation Supervisor - Abbott Laboratories - Hutchinson, KS

Dec 1999-Mar 2000

Chemist - Syntex Agribusiness-Springfield, MO Jun

1994-Mar 1996

Pharmacy Technician Phar-Mor-Springfield, MO

Jun 1992-Oct 1993

Education

. Kaplan University, MBA, Summa Cum Laude, 4.0 GPA

Oct 2008

. University of Santiago, Spain, Certificate, Spanish,

May 2003

. Southwest Missouri State, B.S. Biology/ Minor in Chemistry Magna Cum

Laude Dec 1995

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