7 дней назад
Quality Assurance, On-the-Floor (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance, On-the-Floor (Biotech) (cGMP and pharmaceutical manufacturing): Providing real-time quality oversight for Drug Substance and sterile Drug Product manufacturing at Moderna’s Melbourne site with an accent on GMP compliance, quality systems, and regulatory readiness. Focus on making quality decisions, triaging deviations, reviewing manufacturing documentation, and driving continuous improvement across cross-functional teams.
Location: Melbourne, Australia; site-based and full-time onsite. Not eligible for remote work.
Company
develops mRNA medicines and technologies designed to transform how medicines are created and delivered.
What you will do
- Provide real-time quality oversight of Drug Substance and sterile Drug Product manufacturing operations.
- Monitor process activities for compliance with cGMP requirements, specifications, SOPs, and manufacturing documentation.
- Make quality decisions, identify risks, escalate issues, and troubleshoot manufacturing-suite compliance gaps.
- Partner with Operations, MSAT, and Engineering to initiate and triage deviations and review minor deviation events.
- Author and review SOPs, work instructions, and batch records.
- Support inspection and validation readiness, operational excellence, and continuous improvement initiatives.
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.
- Ability to work full-time at ’s Melbourne site; remote work is not available.
Nice to have
- Experience in sterile drug product manufacturing.
Culture & Benefits
- Healthcare coverage and voluntary benefits, with offerings varying by employment type and country.
- Fitness, mindfulness, and mental health resources.
- Family-building support, including fertility, adoption, and surrogacy benefits.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs, plus location-specific perks.
- In-person collaboration supported through ’s 70/30 work model.
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