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Senior Specialist, Quality Control, Microbiology

Job in Delano, Kern County, California, 93215, USA
Listing for: Moderna
Full Time position
Listed on 2025-12-15
Job specializations:
  • Quality Assurance - QA/QC
    Data Analyst
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

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 solidifying its footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such centre outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We’re looking for talents who can contribute to our innovative research and development efforts.

In this role, you will perform cGMP‑compliant Quality Control (QC) Microbiology testing and data review in support of batch release and stability programmes. You will also contribute to method qualification and acquisition activities, while working hands‑on in a dynamic and highly regulated environment. This role offers a unique opportunity to work on novel mRNA products and engage with modern digital tools in analytical quality control.

The position calls for precise technical execution, regulatory rigor, and a proactive mindset to support Moderna’s quality infrastructure at one of our most advanced international QC hubs.

Here’s

What You’ll Do:

Your key responsibilities will be:
  • Performing microbiological QC testing for release and stability of mRNA medicines in a cGMP environment.
  • Supporting method transfer, development, and troubleshooting for microbiological assays and systems.
  • Reviewing executed assay packages (paper and electronic), including chromatography and analytical outputs.
  • Leading quality system records such as deviations, investigations (OOS), change controls, and CAPAs.
  • Participating in cross‑functional planning to align QC capacity with broader business objectives.
  • Completing and maintaining cGMP documentation according to GDP and data integrity principles.
  • Ensuring testing is performed in compliance with cGMP, GDP, and internal procedures.
  • Authoring and approving SOPs, QC methods, lifecycle documents, and instrument validation records.
  • Generating Certificates of Analysis and assembling stability data packages.
  • Supporting and potentially leading audit and inspection readiness initiatives.
Your responsibilities will also include:
  • Supporting the training and troubleshooting activities for more junior QC staff.
  • Executing tasks as per standard operating procedures and work instructions with precision.
  • Maintaining laboratory records and documentation in compliance with data integrity standards.
  • Managing tools for monitoring QC testing schedules, turnaround time, and performance tracking.
  • Supporting special projects that may span digital QC innovation, compliance enhancements, or generative AI integration for future capability‑building.
The key Moderna Mindsets you’ll need to succeed in the role:
  • We behave like owners. The solutions we’re building go beyond any job description.
    You will be expected to lead initiatives beyond daily testing, contributing to SOP development, audit readiness, data integrity improvements, and continuous compliance innovation, all while driving forward Moderna’s core mission.
  • We digitize everywhere possible using the power of code to maximize our impact on patients.
    At our Madrid site, you’ll have the opportunity to support and embrace digital innovations in QC operations, including analytics‑driven decision making, laboratory information systems, and potential integration with generative AI tools in data trending and visualisation.
Here’s

What You’ll Bring to the Table:
  • BA/BS in a scientific discipline.
  • Working experience: +5 years (or MS in a relevant scientific discipline with 2 years) with a focus in micro testing.
  • Experience with…
Position Requirements
10+ Years work experience
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