Baylie Gigolyk
Brandon,MB
Summary
Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
3
3
years of professional experience
Work History
Quality Assurance Specialist
Pfizer
07.2021 - Current
- Reviewing and approving GxP documentation related to QC, Manufacturing and Engineering activities including SOP’s, Batch Records, protocols, deviations, and work orders, etc.
- Lead Investigator for manufacturing deviations with drive to find true root cause and to develop realistic and effective CAPAs
- Evaluation and certification of new materials to be used in GMP areas and communicating with vendors as necessary
- Scribe and backroom experience for Health Canada and RQA Quality and Safety audits
- Annual Product Record Review and Annual Water Report writing
- Quality Risk Management Facilitator
- Stability Coordinator for Quality Assurance T1
- Implemented continuous improvements to increase productivity in quality assurance operations.
- Yellow Belt, Green Belt, PHP certified
- Brandon PHP representative for API quarterly meetings
- Apart of Brandon Communications team
- Experience with LIMS, SAP
Batch Release Quality
Pfizer
05.2023 - 10.2023
- 6-month Secondment opportunity apart of Rocky Mount remediation project to improve audit and release backlog
- Developed department role process mapping to streamline batch audit and release process
- Performed Audits of Production Batch Records to ensure compliance with cGMP standards
- Completed weekly reporting of departmental improvements and obstacles towards remediation activities
Education
Master of Science - Analytical Chemistry
University of Manitoba
Winnipeg06-2021
Bachelor of Science - Chemistry
University of Manitoba
Winnipeg06-2018
Skills
- Communication
- Teamwork and Collaboration
- Flexible and Adaptable
- Project Management
- Decision Making
Languages
English
Native or Bilingual
Timeline
Batch Release Quality
Pfizer
05.2023 - 10.2023
Quality Assurance Specialist
Pfizer
07.2021 - Current
Master of Science - Analytical Chemistry
University of Manitoba
Bachelor of Science - Chemistry
University of Manitoba
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