Document Controller

at  Moderna

The Role
Joining Moderna offers the unique opportunity to be part of 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. Moderna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients’ lives worldwide.
Moderna is 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. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We’re inviting visionary professionals to be part of this transformative journey making a tangible impact on global health security
Reporting to the Compliance Lead, the GMP Document Control Associate will be part of a cohesive quality assurance team supporting cGMP mRNA drug substances and sterile drug product production manufacturing at Moderna’s state-of-the-art facility. The GMP Document Control Associate is responsible for supporting the completion of department operational tasks related to the record and document lifecycle. This includes issuing, reconciling, processing, scanning, and archiving records to ensure timely availability of documents to support the manufacturing schedule and regulatory requirements.
Here’s What You’ll Do:Your key responsibilities will be:
Support operational tasks related to the record and document lifecycle state, including issuing, reconciling, processing, scanning, and archiving records.
Ensure documents are available in a timely manner to support the operations schedule while maintaining compliance to quality system requirements.
Provide support during regulatory and internal inspections of quality systems.
Assist with the development and ongoing maintenance of an electronic document management system.
Maintain records archives both on-site and at the off-site archive facility.
Manage SOP / Controlled Document listings.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Perform document scanning, filing, and archiving activities.
Create and issue logbooks.
Handle controlled document issuance.
Support the creation and review of ETOgeP (Engineering Turnover Package).
Oversee and track onboarding and training documentation.
Create CQV document listings in line with Equipment Listings.
Input and check data for Asset onboarding in the asset management system (Maximo).
Maintain and control paper-based documents.
Perform any other administrative activities as required by the business.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

Pivot fearlessly: Embrace change and adapt quickly to new information, ensuring the quality and timeliness of document control processes.
Act with urgency: Prioritize tasks to meet the demands of the manufacturing schedule and regulatory requirements, ensuring that documents are processed and available without delay.