Senior Quality Assurance Specialist for Drug Product Manufacturing
4 days ago
About Us
We are a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
We are committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia's ability to respond to future health threats efficiently.
Your Role
You will ensure strict compliance with cGMP standards as a Quality Assurance Specialist for our Melbourne facility, focusing on drug product manufacturing. You will collaborate with cross-functional teams to maintain the highest quality of mRNA drug products, making critical quality decisions and escalating operational issues.
Responsibilities
- Acclimate to our dynamic manufacturing environment within 3 months, understanding specific processes and quality systems.
- Provide on-the-floor quality support, observing manufacturing activities and ensuring compliance with specifications.
- Conduct regular walkthroughs of manufacturing suites, ensuring proper maintenance and adherence to GMP practices.
Key Responsibilities (After 6 Months)
- Make crucial quality decisions and manage escalations that may impact manufacturing operations.
- Collaborate with manufacturing and support teams on new deviation events and minor manufacturing deviations.
- Author and review essential documentation, aligning with regulatory and cGMP requirements.
Key Responsibilities (After 12 Months)
- Enforce cGMP compliance and operational excellence in the manufacturing process.
- Review and ensure the accuracy of batch record documentation.
- Improve operational efficiency and maintain the highest standards of safety and quality in our manufacturing processes.
Requirements
- Bachelor's Degree in a science field or equivalent combination of education and experience.
- 3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
- Sterile drug product manufacturing experienced preferred.
Why Join Us?
We offer personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
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