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Quality Control Analyst
2 months ago
About the Role:
We are seeking a highly skilled Quality Control Analyst to join our team at Moderna Therapeutics Inc. in Melbourne. As a Quality Control Analyst, you will play a critical role in ensuring the quality and safety of our mRNA vaccines.
Key Responsibilities:
- Conduct routine analytical chemistry and stability testing, including HPLC, UPLC, GC, UV, Particle Analysis, KF, and others.
- Perform HPLC and plate reader-based assays supporting manufacturing process stat testing.
- Maintain accurate cGMP documentation for all activities and testing performed.
- Undertake laboratory support activities, including reagent preparation, sample management, and equipment maintenance.
Short-Term Objectives:
- Contribute to Global GMP stability programs, including stability sample set down, pull, and management.
- Engage in stability databases maintenance, performing data trending and statistical analyses.
- Create, review, and revise SOPs, stability protocols, and reports, ensuring compliance with GMP, FDA, EU, and ICH guidelines.
Long-Term Objectives:
- Execute stability sample shipments to external labs and manage stability testing data from external sources.
- Assist in stability studies in LIMS, including data entry, review, and approval.
- Support the preparation of stability sections for regulatory submissions and contribute to quality systems records such as investigations, deviations, change controls, and CAPAs.
Requirements:
- BA/BSc in Chemistry (preferred) or other relevant scientific discipline.
- Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company.
About Moderna Therapeutics Inc.:
Moderna is a leading biotechnology company that is revolutionizing the field of medicine through the development of mRNA-based therapeutics. We are committed to advancing the technological frontier of mRNA medicines and making a significant impact on patients' lives worldwide.
What We Offer:
- Quality healthcare and insurance benefits.
- Lifestyle Spending Accounts to create your own pathway to well-being.
- Free premium access to fitness, nutrition, and mindfulness classes.
- Family planning and adoption benefits.
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown.
- Educational resources.
- Savings and investments.
- Location-specific perks and extras.
Belonging, Inclusion, and Diversity:
Moderna is committed to creating a culture of belonging and diversity, where every employee feels valued and empowered to contribute their best. We believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee can thrive.
