Senior Product Project Management

KATHLEEN KIEFER

**** ****** ****, ***** *******, PA. 16803

*********@*****.***

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

Summary

I am an experienced analytical chemist with experience in senior product quality management, principal scientist roles, quality control supervision in various industries. Extensive expertise in chromatographic method development, troubleshooting, and ISO 9001 and ISO 17025 guidelines. I have experience in developing and writing Standard Operating Procedures, conducting internal audits, and improving business compliance along with customer satisfaction. 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. I am a detailed-oriented team player ready to contribute to enhancing quality processes and outcomes.

Skills

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Organization, Planning and Project Management

Critical Thinking, Analytical Skills, and Problem Solving

Communication

Product Development

Mentoring

Public Speaking

QMS

Experience

Senior Product Quality Agent July 2023 – current

2171 Sandy Drive, State College, PA., United States Videon Central, Inc.

AS9100 and ISO9001

IPC-A-610 Certified IPC Specialist 2023

Incoming Raw Materials, In-Process, and Final Inspection of products

Root Cause Analysis

Shelf-Life and Calibration Coordinator

Create standard operating procedures, NODD/CAPA, and Root Cause Analysis

Generate Monthly Metrics

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

oMasterclass in AS9100D Aerospace Quality

oISO 9001:2015 Quality Management System Auditor

Community

Current Ferguson Township Zoning Hearing Board Member, former chairperson

Penn State Master Gardener – Penn State Extension 1990

Principal Scientist Jan 2019 - Feb 2023

595 N. Harrison Rd, Bellefonte, PA., United States MilliporeSigma

ISO 9001 Internal Auditor

Supervised chemists and laboratory technicians.

Specialized in GC, GC-MS, HPLC, techniques, contributing to new product development of reference standards, gas chromatography capillary columns and accessories based on regulatory requirements and customer input.

Developed and validated analytical methods, ensuring compliance with environmental regulations (500, 600 and 800 series), ASTM, FDA, and AOAC published methodologies.

Authored and reviewed quality assurance documentation (SOP, Master Product Specifications, Labels, Certificates, SDS)

Introduced electronic notebooks.

Monitored and ensured standards were meet during the manufacturing of products (SOPs, GMP, Safety).

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

Supported manufacturing and quality with internal or external issues.

Published Applications:

2022-2023 Chiral Terpenes

2022-2023 Applications on proprietary HPLC columns (ethanol derivatives,

sugars,

2022 Hand Sanitizer, Pitt Con and In-House Seminar

2021 Article Published in Chromatography Today, Sept 1, 2021: Unique Separation of Mint

""Essential Oils by Gas Chromatography Mass Spectrometry Using Two Different Capillary"" (“Industrial Applications of Offline and Online ... - Chromatography Today”) (“Industrial Applications of Offline and Online ... - Chromatography Today”)

Phases: Bonded Polyethylene Glycol and a Novel Ionic Liquid

2019-2021 Mint Oils, Lavender Adulteration, PCB’s and Dioxin

2019 – Update GC Capillary Troubleshooting Guide

2020 Allergen Standards (Bulletin and in-house article created)

2019 Agilent Intuvo Applications configured with Supelco Phases

(Watercol, SPB-624, SLB-5ms, Chiraldex G-TA, SLB-IL60i)

Community

MilliporeSigma Co-Chairwoman in Leadership

Discovery Space

MilliporeSigma Spark Program

Outside Customer Engagement

Former Talbots Catalog and Price Review Agent (Volunteer)

Senior Chemist Jan 1985 - Jan 2019

595 N. Harrison Rd, Bellefonte, PA., United States Sigma Aldrich

ISO 9001 and ISO17025 and Guide 37, ISO 9001 Internal Auditor

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

Managed laboratory teams and support teams achieving significant productivity in product development.

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

Initiated a Stability Program for analytical reference standards.

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.

Internal Awards

Volunteer of the Month - Sigma-Aldrich

Production Liaison/Safety - Sigma-Aldrich

Published Applications/Presentations/Publications

2018 EPA 610 PAH

2018 Water Determination in blended solvents, 1,2 DCE and tetramethylsilane

2018 Allergenic Fragrance Testing - New Certified Reference Materials and

GCFID/GCMS Application for new IFRA method (Analytical Reporter)

2017 NEMC Proficiency Testing- Why You Should Know your P’s and Q’s

2017 Oxygenates

2017 NIST and Quebec PAH

2016 Certified Reference Materials

2016 Unique Indoor Air Standard

2016 Internal: Fact Fiction or Fantasy

2016 Reagent Derivatization Guide and Certificates of Analysis

2014 EAS Improved Analytical Method for the Quantification of Ethylene

Oxide Certified Reference Material

2014 Process Improvement: Improve Efficiency of Certified Reference

Material Transfer Process by 50%

2018 Allergenic Fragrance Testing - New Certified Reference Materials and

GCFID/GCMS Application for new IFRA method (Analytical Reporter)

2017 NEMC Proficiency Testing- Why You Should Know your P’s and Q’s

2016 Certified Reference Materials

2016 Unique Indoor Air Standard

2016 Internal: Fact Fiction or Fantasy

2014 EAS Improved Analytical Method for the Quantification of Ethylene

Oxide Certified Reference Material

2014 Process Improvement: Improve Efficiency of Certified Reference

Material Transfer Process by 50%

2003 Application Note: 37 Component FAME on SPB 1

2002 Food and Beverage Guide

1997 Derivatization of Corn Oil

1996 Comparison of 37 Component FAME Standard on 4

Capillary Columns

1996 Use of BSTFA Silyating Reagent to Prepare Volatile Derivatives for GC

1995 Triazine Pesticide from Dry Pet Food

Quality Control Supervisor Jan 1979 - Jan 1985

595 N. Harrison Rd, Bellefonte, PA., United Staes Supelco Inc

Supervised two shifts 8-10 employees.

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

May 1979, Bachelor of Science, Biology

Marywood University - Scranton, Pennsylvania

Senior Research Project: Growth of Coliform Bacteria with Varying Water Temperature in Treated and Untreated Water.

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