Shahna Coleman
Brisbane,QLD
Summary
Dedicated and detail-oriented biomedical science professional with over three years of experience in GMP-regulated environments, including hands-on roles in pharmaceutical compounding and clinical trials. Experienced in conducting non-conformance investigations, identifying root causes, and proposing effective corrective actions to prevent recurrence. Possess a strong background in SOP writing and updating, with proficiency in laboratory software systems. Seeking to leverage my expertise in biomedical research, laboratory operations, and regulatory compliance to contribute to innovative and high-quality outcomes in a dynamic and challenging research or manufacturing role. Committed to maintaining the highest standards of accuracy, quality, and regulatory adherence while supporting advancements in medical science.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Production Officer
Queensland Institute of Medical Research
Herston, QLD
01.2023 - Current
- Prepared technical documents such as specifications sheets, test reports and batch records according to GMP guidelines.
- Adhered strictly to GMP and GLP guidelines while performing duties related to the manufacturing of human biological cells.
- Provided support during internal and external audits, ensuring compliance with regulatory standards such as GMP and ISO 9001, 2015.
- Non-Conformance Investigation: Proficient in conducting investigations, identifying root causes, and proposing corrective actions to prevent recurrence in GMP-regulated environments.
Production Technician
Slade Health (ICON Group)
Geebung, QLD
01.2022 - 01.2023
- Implemented effective methods for waste reduction initiatives across all departments.
- Provided training and guidance to new employees on operating procedures and production processes.
- Assisted with testing for quality control and corrections.
- Analyzed data from various sources to determine trends in production output.
- Adhered to safety protocols and regulations to ensure a safe working environment for all employees.
Education
Bachelor of Science - Biomedical Sciences
Australian Catholic University
Banyo 12-2023
Skills
- GMP Compliance: Extensive experience in adhering to Good Manufacturing Practices (GMP), including conducting non-conformance investigations, root cause analysis, and implementing corrective actions to ensure regulatory compliance and process improvement
- Dedication and Time Management: Demonstrated ability to effectively balance full-time work and study commitments, showcasing strong dedication, flexibility, and time management skills
- Compassion and Emotional Intelligence: Developed high levels of compassion, empathy, and emotional maturity from volunteering with homeless and marginalized communities, enhancing interpersonal interactions and team collaboration
- Laboratory Safety and Hazard Management: Extensive understanding of laboratory safety and hazard management, gained through theoretical training and practical experience at Slade Health Oncology and QIMR Q-Gen Cell Therapeutics
- Advanced Communication Skills: Proven interpersonal skills and the ability to effectively communicate, developed through extensive experience in customer service roles
- Initiative and Leadership: Demonstrated initiative and leadership by rapidly advancing within managerial roles in previous positions, highlighting the ability to take ownership and drive improvements
Languages
English
Native/ Bilingual
Affiliations
- Volunteer with Emmanuel City Mission since 2021.
- General Membership for the Brisbane Society of Science at ACU since 2020.
Certification
- Cert II in Medical Administration from Medical Administration Training (MAT) - 2021
- Cert II Medical Terminology from Medical Administration Training (MAT) - 2021
References
References available upon request.
Timeline
Production Officer
Queensland Institute of Medical Research
01.2023 - Current
Production Technician
Slade Health (ICON Group)
01.2022 - 01.2023
Bachelor of Science - Biomedical Sciences
Australian Catholic University
- Cert II in Medical Administration from Medical Administration Training (MAT) - 2021
- Cert II Medical Terminology from Medical Administration Training (MAT) - 2021
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