Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

Kimberly Ware

Keenesburg

Summary

Results-driven Quality Control Analyst with extensive experience in pharmaceutical manufacturing and quality assurance, adept at ensuring compliance with cGMP and ALCOA+ standards. Expertise in analyzing finished products, in-process samples, and raw materials, with a proven track record in conducting audits and preparing comprehensive documentation. Strong collaborator with a focus on partnering with cross-functional teams to drive continuous improvement initiatives. Committed to fostering a culture of safety and environmental responsibility while training and mentoring staff to enhance operational excellence.

Overview

33
33
years of professional experience
1
1
Certification

Work History

Quality Control Analyst

Agilent NASD
05.2023 - 09.2025

Support manufacturing through analysis of finished products, in-process samples, and raw materials per BAR specifications. Prepare reagents, standards, and samples for analysis following established methods. Apply hands-on knowledge of analytical instrumentation within QC. Ensure compliance with quality event records and laboratory procedures, maintaining data integrity with ALCOA+ principals. Participate in laboratory cleanliness, dispose of hazardous waste properly, and audit results regularly.

  • Conduct routine audits on results and documentation.
  • Prepare and verify documentation for testing and samples preparations.
  • Collaborate with cross-functional teams to solve problems and drive improvements.
  • Maintained current knowledge through scheduled training and meetings.

Manufacturing Chemist (Advanced)

Agilent NASD
12.2018 - 05.2023

Operated manufacturing process equipment and handled materials effectively. Adhered to written procedures, ensuring accurate documentation per cGMP and Agilent SOP's. Executed various unit operations on raw materials, understanding computer systems for efficiency. Prepared equipment for maintenance while maintaining high housekeeping standards.

  • Initiated and completed assigned tasks proactively, anticipating processing steps.
  • Managed hazardous and non-hazardous waste generation and monitored environmental systems.
  • Trained new Manufacturing Chemists as a Train the Trainer to meet production needs.
  • Demonstrated proficiency in safety rules, tools, and equipment usage.

Production Compression Pharmaceutical Tech 3

Sandoz/Novartis
10.1992 - 11.2018

Coordinated internal training for new and existing Compression Technicians on high-speed compression equipment. Developed formal drafts of SOP's, CPC's, and MBR's for senior management approval. Implemented training programs for new technicians in processing, troubleshooting, set-up, and disassembly. Adhered to cGMP and Sandoz SOP's to document operations accurately.

  • Trained technicians on equipment set-up and in-process operations.
  • Managed hazardous and non-hazardous waste generation responsibly.
  • Collaborated with teams to meet manufacturing goals safely.
  • Updated and redlined SOP's to ensure compliance.

Education

High School -

Thornton High School
Thornton, CO
01-1992

Skills

  • FDA regulations
  • cGMP compliance expertise
  • Effective documentation techniques
  • Experienced with human interface machines
  • Meticulous attention to detail
  • Effective communication
  • Knowledge of ISO standards
  • Standard operating procedure revisions

Certification

  • Agilent Qualified Train the Trainer Agilent Frederick, 2019
  • Novartis Certified Customer Complaint Writer Novartis Broomfield, 2018
  • Novartis Certified Train the Trainer Novartis Broomfield, 2012
  • Certified Fette 2090i (press & turret) Fette America, on-site Broomfield, 2012
  • Certified Fette 1200i Fette America, on-site Broomfield, 2010

Timeline

Quality Control Analyst

Agilent NASD
05.2023 - 09.2025

Manufacturing Chemist (Advanced)

Agilent NASD
12.2018 - 05.2023

Production Compression Pharmaceutical Tech 3

Sandoz/Novartis
10.1992 - 11.2018

High School -

Thornton High School
Kimberly Ware