Analyst, Quality Control

5 months ago

Melbourne, Australia Moderna Full time

**The Role**:
Reporting to the Quality Control Associate Director, the individual in this role will perform cGMP QC testing for QC Chemistry, release, and stability. He/she will also be responsible for supporting Global GMP stability programs, stability sample set down, pull, and sample shipment/receipt activities. Additionally, the individual in this role will be involved in routinely maintaining of stability databases, performing data trending and statistical analyses, creation, revision, review and approval of SOP’s, stability protocols and stability reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations; this individual may support special projects as assigned.

**Here’s What You’ll Do**:
Performs routine analytical chemistry & stability testing including, but not limited to HPLC, UPLC, GC, UV, Particle Analysis by Dynamic Light Scattering, KF, etc.

Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed.

Complete and maintain cGMP documentation for work performed.

Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.

Establish and maintain a safe laboratory working environment.

LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS.

Assists with and executes on ordering of laboratory consumables and supplies. Managing/stocking of QC lab supplies.

Performs stability responsibilities in compliance and in support of any stability program and associated SOP’s.

Creates, reviews and revises stability protocols and reports.

Assists with and performs stability set down and stability pull activities to include, but not limited to labeling, verifying sample quantities, and updating in LIMS and/or appropriate logs/inventory sheets; Supports routine stability sample inventory management, assessment, and sample disposal activities.

Assists with creating stability schedules for GMP stability drug substances and drug products and ensures stability sample pulls occur and are distributed to the test labs as scheduled and within appropriate timelines.

Performs the required functions for stability studies in LIMS, including data entry review and approval.

Assists with and supports reporting of stability testing results both externally and cross-functionally.

Performs trending of stability data and statistical analyses and maintains/ keeps current stability tables and charts for all stability studies.

Supports and executes stability sample shipments to external labs; Requests and retrieves stability testing data/reports from external vendors and shared folders and updates in-house stability binders and databases accordingly.

Supports review and authoring of applicable stability sections for regulatory submissions.

May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.

Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.

**Here’s What You’ll Bring to the Table**:
BA/BSc in Chemistry (preferred) or other relevant scientific discipline.

**Working experience**: at least 5-7 years in quality control laboratory of a pharmaceutical company.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Moderna is a smoke-free, alcohol-f

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