KATHLEEN KIEFER

ad4zoj@r.postjobfree.com

LinkedIn Profile: www.linkedin.com/in/kathleen-kiefer-0a56a9264

Summary

I am a seasoned analytical chemist with extensive experience in senior product quality management, principal scientist roles, quality control supervision in biotechnology, chromatographic method development, troubleshooting, ISO guidelines, and manufacturing. My expertise extends to using collaboration tools for remote work, ensuring seamless communication and project management. I am adept at adapting to new technologies and methodologies, making me an ideal candidate for roles requiring analytical precision and regulatory compliance. I communicate with proficiency in delivering the objectives of the program to ensure all members feel successful. My aim is to leverage my skills in improving business compliance, workflow, and processes. Preferred locations include remote opportunities and industries such as pharmaceuticals, aerospace, and healthcare.

Experience

Senior Product Quality Agent July 2023 – current

Videon Central, Inc., State College, PA

Implemented QA policies to align with ISO 9001, enhancing product compliance and efficiency.

Leveraged collaboration tools for remote team coordination, improving process optimization and cost reduction.

Conducted comprehensive data analysis and recommended corrective actions to maintain high-quality standards.

IPC-A-610 Certified IPC Specialist 2023

Millipore Sigma Worldwide Lay Off, Division of Merck, Germany Feb 2023 – July 2023

Spent time looking for a new position.

Principal Scientist Jan 2019 - Feb 2023

MilliporeSigma, Bellefonte, PA.

Specialized in GC, GC-MS, HPLC, and other EPA methods (CLP, SW-846), contributing to new product development.

Developed and validated analytical methods, ensuring compliance with environmental regulations.

Authored and reviewed quality assurance documentation.

ISO 9001 Internal Auditor.

Introduced electronic notebooks.

Monitored and ensured standards were meet during the manufacturing of products.

Performed root cause analysis for out-of-spec products, ensuring continuous improvement in quality control.

Resolved/Improved manufacturing issues (examples: glass wool, evaluation of septa vendors, raw material sourcing for production.

Written articles and presented talks at national conferences.

Senior Chemist Jan 1985 - Jan 2019

Supelco, Rohm and Haas, Sigma Aldrich, and MilliporeSigma

Launched new analytical reference standards per ISO/IEC 17025, enhancing laboratory accuracy and reliability. Over 30 new products introduced yearly.

Managed laboratory teams, achieving significant productivity in product development.

Trained manufacturing personnel, sales, and technical specialist on the use of products, and processes.

Initiated Stability Program for analytical reference standards.

Performed root cause analysis for out-of-spec products, ensuring continuous improvement in quality control.

ISO 9001 and ISO 17025 Internal Auditor

Developing method validation procedures and method development for raw materials, intermediates, and finished goods.

Qualified vendors.

CAPA team leader, reviewing 3-4 efficiency checks per month according to ISO 9001

standards.

Quality Control Supervisor Jan 1979 - Jan 1985

Supelco Inc

Oversaw quality control processes, identifying improvement areas and implementing solutions.

Maintained testing equipment, ensuring the qualification of all products met stringent standards.

Established quality department goals, significantly improving customer satisfaction and product reliability. Responsible for Lipids, Gas and High-Pressure Liquid Chromatography, Machine Shop, Glass Shop, Packaging product lines.

Education

Bachelor of Science, Biology

Marywood University - Scranton, Pennsylvania

Senior Research Project: Growth of Coliform Bacteria with Varying Water Temperature in

Treated and Untreated Water.

Continuing Education

On-Line courses –

oCost of Quality Analysis and Reporting with Microsoft Excel

oMastering the Seven Quality Tools

oRoot Cause Analysis and the 8D Corrective Action Process

oJira and Confluence Training

oRoot Cause Analysis

o5W2H Problem-Solving Method

oEight Disciplines (problem solving methodology to address, correct, and eliminate recurring problems impacting business operations, manufacturing, and product development.

oLean Six Sigma White Belt Certification

Skills

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Critical Thinking

Organization

Problem Solving

Product Development

Analytical Skills

Public Speaking

Mentoring

Accomplishments

Penn State Master Gardener – Penn State Extension 1990

Millipore Sigma Co-Chairwoman in Leadership

Volunteer of the Month - Sigma-Aldrich

Production Liaison/Safety - Sigma-Aldrich

Former Ferguson Township Zoning Chairperson

Former Talbots Catalog and Price review

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