Summary
Overview
Work History
Education
Skills
Certificatesandtraining
Timeline
Generic

Kaci Puhalla

McPherson,Ks

Summary

Methodical Quality Assurance Investigation Approver with superb problem-solving and analytical abilities. Keeps meticulous records and identify and troubleshoot problems. Specialties include operational improvements, program implementation and documentation.

Overview

2025
2025
years of professional experience

Work History

Site Quality Authority

- Current
  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
  • Suggest improvements and conduct continuous improvement activities
  • Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices impacts
  • Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices practices
  • Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations perspectives.

Quality Operations Professional / Senior Quality Operations Professional

Hospira, A Pfizer Company
02.2018 - 10.2022
  • Independently provides Real Time Quality impact assessments and decisions (24/7) on Drug Product issues as needed
  • Participate in QAR Gembas with customers and peers
  • Effectively communicate complex technical issues to all levels of Management
  • Subject Matter Expert support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns
  • Assisted in creating and presenting quarterly trainings to the team to build on existing skills and build new skills
  • Create a mentorship and training program for onboarding new Quality Operations Professionals to ensure a smooth transition and provide colleagues with the tools needed to succeed
  • Support the Quality organization with IMEx implementation and continuous improvement activities
  • Leads Quality Tier 1 daily Meeting discussing new deviations and potential regulatory and supply risks.

Manufacturing Quality Assurance Auditor/ Inspector

Hospira, A Pfizer Company
08.2015 - 02.2018
  • Audited compliance of product and processes against written specifications
  • Performed visual inspection audits on vials, carpujects, syringes, and ampules
  • Placed products on hold when needed to ensure company integrity per SOP’s
  • Performed examinations and destructions on all controlled and non-controlled products
  • Compiled documentation of all steps taken related to the manufacture, testing and packaging of products
  • Created sampling records and performed in-process sampling of batches
  • Completed, understands and enforces all Standard Operating Procedures and Training Course Plans
  • Completed Required Certified Trainer training, signs off TCP’s and all other associated trainings
  • Performed final review of Manufacturing quality batch records.

Education

Bachelor’s Degree in Animal Science -

Kansas State University
Manhattan, KS
05.2015

Skills

GMP Knowledge

CAPA Management

Quality Metrics

Documentation Control

Quality Management Systems

Six Sigma Methodologies

Certificatesandtraining

  • Certified Trainer
  • Trained in First Aid
  • Trained on Automatic External Defibrillator
  • Proficient in Microsoft Office, Word, Power Point, Access and Excel

Timeline

Quality Operations Professional / Senior Quality Operations Professional

Hospira, A Pfizer Company
02.2018 - 10.2022

Manufacturing Quality Assurance Auditor/ Inspector

Hospira, A Pfizer Company
08.2015 - 02.2018

Site Quality Authority

- Current

Bachelor’s Degree in Animal Science -

Kansas State University

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Kaci Puhalla