Marcus Thompson
42 Glenbrook Drive, Penrith NSW 2750
0412 847 563 | marcus.thompson@email.com


PROFESSIONAL SUMMARY

Detail-oriented QA Officer with 6+ years of experience in quality assurance within pharmaceutical and biotechnology manufacturing environments. Proven expertise in GMP compliance, process validation, environmental monitoring, and regulatory documentation. Strong background in conducting internal audits, investigations, and risk assessments to ensure product quality and regulatory adherence. Skilled in training cross-functional teams and implementing quality systems that support continuous improvement initiatives.


PROFESSIONAL EXPERIENCE

QA Officer
Medtech Solutions Australia, Melbourne VIC
March 2021 – Present

• Conduct routine GMP compliance audits across manufacturing, warehousing, and upstream processing areas, identifying non-conformances and implementing corrective actions that reduced deviations by 32%
• Oversee environmental monitoring programs including sampling protocols for cleanrooms, water systems, and compressed gas utilities, ensuring ATP testing and microbial limits compliance
• Lead investigation activities for quality events, deviations, and out-of-specification results, completing root cause analysis and CAPA documentation within established timelines
• Review and approve batch records, validation protocols, and manufacturing documentation for biotechnology products, maintaining 100% audit readiness
• Develop and deliver GMP training programs to 150+ employees across production, quality, and warehousing departments, achieving 98% training completion rate
• Coordinate pest control programs and facility monitoring activities to maintain controlled manufacturing environments


QA Associate
BioPharm Pty Ltd, Brisbane QLD
June 2018 – February 2021

• Performed quality assurance review of batch manufacturing records, testing data, and supply chain documentation for pharmaceutical products
• Supported process validation activities including IQ/OQ/PQ protocols for equipment and automated systems in manufacturing operations
• Conducted internal audits of quality systems, documentation practices, and GMP compliance across multiple production lines
• Assisted in risk assessment activities for change controls, deviations, and process improvements using structured methodologies
• Maintained quality records systems and ensured document control procedures met regulatory requirements
• Participated in regulatory inspections and external audits, providing documentation and technical support


Quality Control Technician
Australasian Biotech Industries, Sydney NSW
August 2016 – May 2018

• Executed sampling and testing protocols for raw materials, in-process samples, and finished products in biotechnology manufacturing
• Performed environmental monitoring including viable and non-viable particulate testing in classified areas
• Documented test results and maintained laboratory records in compliance with GMP and data integrity requirements
• Operated and maintained analytical equipment, completing calibration and qualification activities
• Supported validation activities for analytical methods and laboratory equipment
• Collaborated with manufacturing and quality teams to investigate out-of-specification results


EDUCATION

Bachelor of Science in Biology
University of New South Wales, Sydney NSW
Graduated: May 2016


CERTIFICATIONS & TRAINING

• Certified Quality Auditor (CQA) – ASQ
• GMP Training Certification
• Root Cause Analysis and CAPA Training
• Risk Assessment and Management Certification
• Internal Auditor Training – ISO 9001


TECHNICAL SKILLS

Quality Systems: GMP, Quality Assurance, Process Validation, Internal Audit, Risk Assessment, Investigation, CAPA
Manufacturing: Biotechnology, Upstream Processing, Manufacturing Operations, Automation, Supply Chain
Testing & Monitoring: Environmental Monitoring, ATP Testing, Sampling, Testing Protocols, Data Analysis
Documentation: Protocol Development, Records Management, Documentation Review, Regulatory Documentation
Tools & Software: Microsoft Office Suite, Quality Management Systems, Electronic Batch Records
Other: Training Development, Pest Control Programs, Warehousing Operations, Gas Systems Management


LANGUAGES

English – Native
Mandarin – Professional Working Proficiency


PROFESSIONAL AFFILIATIONS

• American Society for Quality (ASQ)
• Parenteral Drug Association (PDA)