Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic
Katie Banaszewski

Katie Banaszewski

Schaumburg,IL

Summary

A dynamic and results-oriented Sr. Director of Quality with over 15 years of hands-on experience as a leader in quality control, quality assurance, research and development, and regulatory compliance. Recognized for adeptly building and nurturing high-performing teams with a keen focus on fostering collaboration and achieving organizational goals. Proficient in managing and mentoring direct reports, demonstrating a track record of guiding teams to success while maintaining a steadfast commitment to quality and regulatory standards.

Overview

19
19
years of professional experience

Work History

Sr. Director of Quality

NOW Health Group
Bloomingdale, IL
09.2021 - Current
  • Spearheads comprehensive quality management initiatives, encompassing quality control, regulatory compliance, method development, and quality engineering, enhancing operational efficiency and compliance
  • Oversees and manages policies, programs, and initiatives, leading to a substantial increase in quality assurance standards adherence and a significant reduction in compliance issues
  • Directs the activities of the analytical, physical, and microbiological testing labs
  • Leads the R&D team in formulating and developing new products, resulting in the launch of a minimum of 60 new products per year and the improvement of manufacturing capabilities by 30%
  • Oversees customer complaints, deviations, product recalls, change control, and root cause analysis
  • Improved quality audit programs for contract manufacturers, reducing deviations by 17% through rigorous compliance tracking and supplier quality audits
  • Directs the implementation of quality and process improvement initiatives in conjunction with Quality, R&D, Supply Chain, Operations, and other functional personnel to deliver results and ensure products/processes meet quality standards
  • Led regulatory compliance initiatives that resulted in successful FDA and ISO audits, minimizing compliance risks and ensuring adherence to cGMP standards
  • Develops, recommends, and implements systems, processes, and activities to improve productivity and timeliness across the quality organization
  • Oversees the Science and Nutrition department, including label compliance and advocacy
  • Collaborates closely with supply chain and sourcing teams to establish quality benchmarks for raw materials, reducing defective materials by 25% and improving supplier accountability
  • Prepares and presents quarterly quality, compliance, and R&D reports to executive leadership, providing actionable insights that guide strategic decision-making and enhance compliance visibility
  • Manages a team of over 300 with nine direct reports

Analytical Lab Manager

NOW Health Group
Bloomingdale, IL
03.2020 - 09.2021
  • Managed Analytical Lab Supervisors, Stability Supervisor, Method Development & LIMS teams, and R&D NPD team
  • Directed implementation of new systems to streamline and improve current processes, including LIMS modules, Chromeleon software, and PM software upgrades
  • Collaborated closely with the Science, Marketing, and Food teams to direct R&D NPD efforts
  • Provided scientific expertise to the Customer Complaints team and International Sales team
  • Provided support to the Manufacturing Quality team whenever necessary and assisted in troubleshooting material issues
  • Collaborated with instrument vendors and continuously introduced new technologies and applications to the analytical lab
  • Responsible for obtaining and maintaining ISO 17025 accreditation for the laboratory and expanding its scope
  • Involved in each team's activities, providing support, setting objectives, and measuring performance

Method Development Supervisor

NOW Foods
Bloomingdale, IL
07.2018 - 03.2020
  • Led a team of five analytical scientists and provided expertise in mass spectrometry
  • Led the pesticide residue monitoring program implementation at NOW Foods and actively aided the team with challenges in sample preparation or analysis of pesticides in botanical matrices
  • Wrote journal articles, presented work at scientific conferences, and contributed to the scientific community through volunteering and participation in working groups
  • Collaborated with vendors to provide feedback on improving their hardware or software solutions
  • Served as a resource to the QC laboratory, R&D, and upper management at NOW Foods

Analytical Scientist III

NOW Foods
Bloomingdale, IL
04.2013 - 07.2018
  • Developed and validated methods for testing raw materials and finished products in-house and used innovative and creative approaches to develop identification methods for botanical materials
  • Served as an expert in the areas of LC TOF, LC-MS, GC-MS, HPLC, and ICP-MS
  • Participated in scientific meetings and presented work in the form of poster and oral presentations
  • Networked with scientists worldwide to stay up to date with current methodology and issues pertaining to the dietary supplement industry

Sr. Mass Spectrometry Scientist and Chemistry Supervisor

Certified Laboratories
Bolingbrook, IL
10.2012 - 04.2013
  • Worked as a consultant for the analytical chemistry team and led method development and validation at the Long Island location
  • Supervised a team of seven analytical chemists at the Long Island Certified Laboratories location and was responsible for all chemistry operations
  • Expanded the scope of tests and managed the Bolingbrook chemistry team, prepared the laboratory for the A2LA audit, and received ISO 17025 accreditation for chemistry analyses

Sr. Support Scientist

Institute for Food Safety and Health
Bedford Park, IL
11.2007 - 10.2012
  • Designed experiments independently, tested objectives, and analyzed data in various research fields
  • Responsible for maintaining analytical instrumentation, developing and validating methods, and working closely with manufacturers to create application notes
  • Presented my novel work through posters and publications and helped market and facilitate instrument sales
  • Drafted science papers, grants, and project proposals

Senior Microbiology Lab Technician

Mars Snackfood US
Hackettstown, NJ
11.2005 - 11.2007
  • Assessed the microbiological situations, managed the daily operations of the Corporate Microbiology Lab, and implemented QA programs and procedures
  • Developed and validated sampling and testing protocols for microbiological testing of products
  • Provided expert consultation on microbiological issues to vendors and QA managers

Education

Bachelor of Science - Biotechnology

William Paterson University
Wayne, NJ

Master of Science - Biology

University of Warmia and Mazury
Olsztyn, Poland

Skills

  • Communication
  • Leadership
  • Problem solving
  • Risk management
  • Quality control
  • Quality assurance
  • Process improvement
  • Strategic planning
  • Team building
  • Regulatory compliance
  • Research and Development
  • Vendor Qualification
  • 21 CFR 111
  • 21 CFR 117
  • CGMP
  • Six Sigma
  • Team management

Affiliations

  • Member of AHPA (American Herbal Products Association) Board of Trustees
  • Member of UNPA (United Natural Product Association)
  • Member of ABC (American Botanical Council)
  • Member of IADSA (International Alliance of Dietary/Food Supplements Association Company Council)
  • Member of WIN (Women in Nutraceuticals)
  • Member of NPA (Natural Product Association)
  • Member of OTA (Organic Trade Association) Council
  • Member of AOAC (Association of Official Agricultural Chemists)

Timeline

Sr. Director of Quality

NOW Health Group
09.2021 - Current

Analytical Lab Manager

NOW Health Group
03.2020 - 09.2021

Method Development Supervisor

NOW Foods
07.2018 - 03.2020

Analytical Scientist III

NOW Foods
04.2013 - 07.2018

Sr. Mass Spectrometry Scientist and Chemistry Supervisor

Certified Laboratories
10.2012 - 04.2013

Sr. Support Scientist

Institute for Food Safety and Health
11.2007 - 10.2012

Senior Microbiology Lab Technician

Mars Snackfood US
11.2005 - 11.2007

Bachelor of Science - Biotechnology

William Paterson University

Master of Science - Biology

University of Warmia and Mazury

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Katie Banaszewski