Megan King
- Phone: +61 2 9123 4567
- Email: megan.king@email.com
- Location: Sydney, Australia
- LinkedIn: megan-king-qc
Summary
Six years of experience ensuring product quality and regulatory compliance within pharmaceutical manufacturing environments. Consistently reduced batch rejection rates by implementing robust sampling and testing protocols, contributing to a 15% improvement in overall production efficiency. Adept at operating and troubleshooting analytical instrumentation and meticulously documenting quality control processes.
Experience
Senior Quality Control Analyst, PharmaCo Australia -- Sydney, Australia
Mar 2020 – present
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Led a team of 3 junior analysts in daily QC operations, ensuring adherence to TGA and GMP standards for pharmaceutical products.
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Developed and implemented new analytical methods for raw materials and finished products, resulting in a 10% reduction in testing turnaround time.
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Conducted comprehensive investigations into out-of-specification (OOS) results, identifying root causes and recommending corrective actions to prevent recurrence.
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Performed routine calibration and maintenance of laboratory equipment, including HPLC, GC, and spectrophotometers, ensuring data integrity and reliability.
Quality Control Analyst, AustraBio Labs -- Sydney, Australia
June 2017 – Feb 2020
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Executed in-process and final product testing for biologics, maintaining a 99.5% accuracy rate in analysis.
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Assisted in the validation of new laboratory equipment and analytical procedures, contributing to the expansion of testing capabilities.
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Managed and maintained detailed laboratory records, ensuring full traceability and compliance with internal and external audits.
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Trained new team members on standard operating procedures (SOPs) for various analytical techniques and quality control processes.
Education
University of Sydney, BSc in Bachelor of Science in Chemistry -- Sydney, Australia
Feb 2013 – Nov 2016
Skills
Analytical Techniques: HPLC, GC, UV/Vis Spectroscopy, FTIR, pH Meter, Titration, Dissolution Testing, KF Titration, Microbiology Testing
Quality Systems: GMP, GLP, TGA Regulations, ISO 9001, OOS Investigations, CAPA, Change Control, Deviations, Risk Assessment
Laboratory Software: LIMS, Empower, ChemStation, Microsoft Office Suite, SAP QM
Other Skills: Method Validation, Equipment Calibration, Data Analysis, Technical Documentation, Problem Solving, Team Leadership
