Senior Specialist, On-the-Floor, Quality Assurance

Location: Melbourne, Australia; site-based full-time and not eligible for remote work

Company

hirify.global develops mRNA medicines and operates a global mRNA technology platform focused on transforming medicine.

What you will do

• Provide real-time QA oversight across manufacturing operations and QC laboratories supporting cGMP mRNA drug substance production.
• Conduct walkthroughs and review manufacturing, laboratory, batch record, documentation, facility, contamination control, and data integrity practices.
• Manage and oversee deviations, OOS/OOT investigations, laboratory non-conformances, risk assessments, change controls, and CAPA activities.
• Author, review, and approve SOPs, work instructions, protocols, reports, APQR inputs, technical assessments, and other GMP documentation.
• Support analytical and microbiological method lifecycle activities, stability programs, reference standards, external laboratories, and QC data trending.
• Contribute to inspection readiness, TGA inspection support, personnel coaching, continuous improvement, digital quality initiatives, and responsible adoption of AI-enabled solutions.

Requirements

• Bachelor’s degree in a relevant science or engineering field, or an equivalent combination of education and experience.
• At least 5 years of pharmaceutical, biopharmaceutical, or related experience with an emphasis on cGMP.
• Working knowledge of quality systems and electronic systems such as SAP, LIMS, MODA, eLN, CDS, and electronic batch records.
• Strong knowledge of cGMP regulations, ISO standards, data integrity, deviations, CAPAs, risk assessments, and regulatory expectations.
• Experience with QA on-the-floor support, QC laboratories, investigations, method lifecycle management, microbiology, environmental monitoring, or contamination control.
• Must work full-time at hirify.global’s Melbourne site; remote work is not available.

Nice to have

• Experience supporting regulatory inspections or audits as a subject matter expert.
• Experience with analytical or microbiological method validation, transfer, qualification, or lifecycle management.
• Experience with QC microbiology, clean utilities, contamination control, and laboratory controls.
• Strong leadership, coaching, communication, project management, and organizational skills.

Culture & Benefits

• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• 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 benefits.