# Senior Specialist, On-the-Floor, Quality Assurance

Hiring organization: [Moderna](https://career.thegoodapps.co/organizations/moderna)

Canonical page: https://career.thegoodapps.co/jobs/43c06073-7b9c-40f5-8c46-0320e1c5435f

Listed on Moderna's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior

## Summary

A quality assurance specialist providing real-time oversight of mRNA drug manufacturing and quality control operations at Moderna's Melbourne facility, ensuring compliance with cGMP standards and supporting continuous improvement. Ideal for someone with pharmaceutical manufacturing experience who enjoys hands-on quality work, cross-functional collaboration, and making direct patient impact in a high-growth biotech environment.

_Our summary, not Moderna's wording._

## Skills named

Change Control, Corrective And Preventive Action (CAPA), Data Integrity, SAP

## Required

- Bachelor's degree in science field (Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent
- Minimum 5 years pharmaceutical, biopharmaceutical, or related work experience with cGMP emphasis
- Working knowledge of Quality Systems and electronic systems (SAP, LIMS, MODA, eLN, CDS, batch records)
- Site-based role in Melbourne, full-time on-location presence required

## Nice to have

- Strong working knowledge of cGMP regulations, ISO standards, data integrity expectations, and regulatory guidance
- QA on-the-floor support experience in manufacturing operations and/or QC laboratories
- Experience with regulatory inspections or audits as SME with health authority interaction
- Experience with analytical or microbiological method validation, transfer, or qualification
- Experience with OOS/OOT investigation management, deviations, and CAPAs
- Understanding of QC microbiology, environmental monitoring, and contamination control
- Ability to make risk-based quality decisions and escalate appropriately
- Leadership, coaching, communication, and project management skills

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/Melbourne---Australia/Senior-Specialist--On-the-Floor--Quality-Assurance_R19499