Summary
Overview
Work History
Education
Skills
Affiliations
Training
Timeline
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Sasha McEvoy

Burleigh Heads

Summary

Experienced scientist with over 10 years in diverse laboratory environments across various industries, offering extensive knowledge and practical skills. Recently relocated to the Gold Coast after a career break, now eager to re-enter the workforce in a school laboratory setting while pursuing a Master of Teaching (Secondary). Committed to fostering hands-on learning experiences for students and contributing to educational excellence. Passionate about leveraging scientific expertise to inspire the next generation of learners.

Overview

10
10
years of professional experience

Work History

Senior Production Scientist/Supervisor

Queensland Tissue Bank
09.2023 - 12.2024
  • Oversight and support of production & operational activities to manufacture tissue products processed from deceased donor tissue (skin, musculoskeletal, cardiovascular and ocular tissue types)
  • Participate and execute aseptic operator qualifications, equipment qualifications, compiling results for disinfectant validations and test method validations.
  • Reallocating workloads across team members to ensure timelines are met, without reducing quality of work or output from the team.

Quality Manager

Biotest Laboratories Pty Ltd
02.2023 - 05.2023
  • Oversight of the cleanroom facility including training of staff for gowning and testing products, schedule of sterility and biologicals testing, review of environmental monitoring, trending microbial isolates and investigating Out of Specification results.
  • Documenting and approving Change Controls, Corrective & Preventative Action Plans, Out of Specification reports, Method Deviations and Risk Assessments
  • Reviewing of equipment data, environmental monitoring, and investigation outcomes.
  • Redundancy after Symbio Acquisition

Senior Pharmaceutical Microbiologist

Biotest Laboratories Pty Ltd
04.2020 - 01.2023
  • Discuss and explain test results to manufacturers of sterile injectables, veterinary medicine, nutraceuticals, pharmaceuticals, biologicals and cosmetics.
  • Execution of projects, R&D work, investigative microbiology, challenge testing and disinfectant qualifications.
  • Preparing stock cultures of bacterial, fungal and spore forming organisms.
  • Conducting Out of Specification investigations, Corrective and Preventative Action Plans, Change Controls and Method Deviations as well as relevant Risk Assessments and Root Cause Analysis.
  • Oversight and organisation of the cleanroom facility with two ISO Class 5 cleanrooms for performing testing of biological samples, as well as sterility testing of sterile biologics, injectables, veterinary and medicinal products, medical devices etc.
  • Troubleshooting and problem-solving skills highly developed in this role.
  • Participation in TGA audits as well as client audits both on-site and online, including preparation of audit responses and corrective action plans.
  • Review and reporting of laboratory results (both sterile and non-sterile products), communication point between clients and the microbiology team.
  • Provide guidance to microbiology team when dealing with gross contamination events, participation in cleaning activities of laboratory, cleanroom facility and microbiological equipment.
  • Updating SOP’s and training staff on changes to procedures, including implementing continuous improvement.

Microbiologist & Laboratory Supervisor

Biotest Laboratories Pty Ltd
07.2014 - 02.2020
  • Maintaining stock cultures of bacterial & fungal cultures, as well as maintaining stock counts for sporulating organisms.
  • Testing of products following GMP & SOP’s for products including sterile injectables, veterinary medicine, nutraceuticals, pharmaceuticals, biologicals and cosmetics.
  • Training of staff for microbiology benchwork activities ranging from sample receipt & handling, preparing samples for testing, performing confirmatory tests, reading plates and interpreting results, sterility testing and use of Biological Safety Cabinets, cleaning & sanitation procedures, media quality control testing, document control and investigation procedures.
  • Preservative Efficacy Testing of cosmetic products and sterile injectables.
  • Leading a team of ~10 (scientists and laboratory technicians) to ensure samples were tested correctly and in a timely manner.
  • Delegating tasks and organising workloads to ensure minimum overtime of all staff & optimum efficiency of laboratory workflow.
  • Recording results and notifying reporting personnel and senior management of Out of Trend and Out of Specification results.

Education

Graduate Certificate - Good Manufacturing Practice

University of Technology
11.2023

Bachelor of Science - Microbiology

University of Queensland
06.2015

Skills

  • Cell culture techniques
  • Microscopy techniques
  • Analytical chemistry
  • Safety procedures
  • Laboratory management & compliance
  • Problem-solving abilities
  • Attention to detail

Affiliations

  • Australian Society of Microbiology (ASM)
  • International Society of Pharmaceutical Engineering (ISPE)

Training

  • PharmOut GMP Courses:
  • Annex 1 Workshop (November 2022)
  • Cleaning Validation, Data Integrity, Deviations & Non-conformances (March 2023)
  • Qualification & Validations, Quality Risk Management, CAPAs, Introduction to Practical Auditing (July 2023)
  • QLD Health Courses:
  • Conducting Performance Development Plans (July 2024)

Timeline

Senior Production Scientist/Supervisor

Queensland Tissue Bank
09.2023 - 12.2024

Quality Manager

Biotest Laboratories Pty Ltd
02.2023 - 05.2023

Senior Pharmaceutical Microbiologist

Biotest Laboratories Pty Ltd
04.2020 - 01.2023

Microbiologist & Laboratory Supervisor

Biotest Laboratories Pty Ltd
07.2014 - 02.2020

Bachelor of Science - Microbiology

University of Queensland

Graduate Certificate - Good Manufacturing Practice

University of Technology

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Sasha McEvoy