Summary
Overview
Work History
Education
Skills
Certification
Technical Skills
Timeline
AdministrativeAssistant

Christine Patko

QA Auditor
Birmingham,AL

Summary

Methodical and detail-oriented Quality Assurance Auditor with 10 years of experience in the pharmaceutical and medical device industry. Contains an in-depth knowledge of cGMP principles and able to identify breach of cGMP principles and collaborate to determine solutions.

Overview

10
10
years of professional experience

Work History

QA Auditor / Materials Management

Evonik Corporation
08.2022 - Current
  • Manage Supplier Qualification and Internal Audit programs by planning and executing GMP and ISO audits as lead auditor
  • Prepare audit reports to communicate non-compliances to auditees, and collaborate with auditees for prompt responses and resolutions to identified issues
  • Qualify new raw material manufacturers and service providers by performing risk-based and phase-appropriate assessments and subsequent qualifications
  • Execute Quality reviews and approvals for CAPAs, deviations, change controls, supplier complaints, risk assessments, and material specifications
  • Improve procedures and tools for supplier management to ensure compliance with applicable regulations

Quality Assurance Specialist

Evonik Corporation
01.2020 - 08.2022
  • Dispositioned GMP polymer and medical device component batch records, and reviewed analytical test reports for completeness, compliance, and conformance to approved specifications, while meeting tight customer timelines
  • Supported regulatory audits, internal audits, and customer audits
  • Executed periodic internal audits of manufacturing cleanrooms, quality control laboratories, and microbiology laboratories
  • Onboarded, trained, and mentored a team of Quality Specialists, and average review time of batch documents improved by 350% within 6 months
  • Streamlined Quality’s involvement in finished product shipping processes for a 75% gain in overall efficiency
  • Provided Quality guidance for the resolution of deviations, risk assessments, and change controls via TrackWise
  • Improved the Supplier Qualification program for 50% increased efficiency

Associate Scientist

Evonik Corporation
09.2013 - 01.2020
  • Developed as subject matter expert and technical lead for HPLC and GPC; performed international GPC method transfer from Germany to Birmingham
  • Executed method validations and verifications and reviewed validation protocols for completeness and compliance
  • Restructured visual inspection training program for finished products
  • Pioneered initiative to streamline laboratory documentation which resulted in a 75% gain in documentation efficiency

QC Scientist

Avanti Polar Lipids
01.2012 - 07.2012
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Organized and detail-oriented with a strong work ethic.
  • Paid attention to detail while completing assignments.

Education

Bachelor of Science - Chemistry

University of Alabama At Birmingham

Skills

  • ISO 9001
  • Quality Assurance and Control
  • Quality Standards Adherence
  • Compliance Requirements
  • Audit Process Management
  • Current Good Manufacturing Practices (CGMP)

Certification

ISO 9001 Lead Auditor

Aug 2021

Technical Skills

  • TrackWise
  • SAP
  • MasterControl
  • Regulus
  • Microsoft Office

Timeline

QA Auditor / Materials Management

Evonik Corporation
08.2022 - Current

Quality Assurance Specialist

Evonik Corporation
01.2020 - 08.2022

Associate Scientist

Evonik Corporation
09.2013 - 01.2020

QC Scientist

Avanti Polar Lipids
01.2012 - 07.2012

Bachelor of Science - Chemistry

University of Alabama At Birmingham

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Christine PatkoQA Auditor