5 дней назад
Quality Assurance, On-the-Floor (GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance, On-the-Floor (GMP): Providing real-time quality oversight for Drug Substance and sterile Drug Product manufacturing at Moderna’s Melbourne site with an accent on cGMP compliance, quality systems, and manufacturing documentation. Focus on monitoring manufacturing operations, making quality decisions, managing deviations, and supporting inspection and validation readiness.
Location: Melbourne, Australia; site-based full-time with no remote work
Company
develops mRNA-based medicines, vaccines, and manufacturing technologies for therapeutic and infectious disease applications.
What you will do
- Provide real-time quality oversight for Drug Substance and sterile Drug Product manufacturing.
- Monitor manufacturing operations, walkthroughs, and documentation for cGMP and regulatory compliance.
- Make quality decisions, identify risks, escalate issues, and troubleshoot quality gaps affecting operations or product quality.
- Partner with Operations, MSAT, and Engineering to initiate and triage deviations and review minor deviations.
- Author and review SOPs, work instructions, and batch records.
- Support continuous improvement, safe work practices, and readiness for inspections and validation activities.
Requirements
- Bachelor’s degree in a science-related field such as Biology, Microbiology, Chemistry, Pharmacy, or Engineering, or equivalent experience.
- 3–5 years of pharmaceutical or related experience in a GMP environment.
- Strong understanding of cGMP requirements and quality systems.
- Ability to make independent quality decisions and escalate issues appropriately.
- Strong cross-functional collaboration, communication, attention to detail, and compliance focus.
- Must work full-time at the Melbourne site; the position is not eligible for remote work.
Nice to have
- Experience in sterile drug product manufacturing.
Culture & Benefits
- Healthcare and voluntary benefits tailored to employee needs.
- Fitness, mindfulness, mental health, and broader well-being resources.
- Family-building support, including fertility, adoption, and surrogacy benefits.
- Paid vacation, bank holidays, volunteer days, sabbatical, recharge days, and discretionary year-end shutdown.
- Savings and investment programs plus location-specific benefits.
- In-person collaboration supported through ’s 70/30 work model.
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