Description:
Moderna is seeking a Quality Assurance Specialist responsible for real time on the floor quality oversight of internal manufacturing at Moderna Inc. The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug substance produced internally at Moderna and will work cross-functionally with Operations, Manufacturing Science and Technology, and other functions. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to the Quality System. Strong decision-making skills and independent thinking will be paramount for candidate success. They will be expected to make decisions and/or escalate issues to management that occur during operations.
Here’s What You’ll Do:
Your key responsibilities will be:
- Provide on-the-floor Quality support to Manufacturing (Drug Substance and sterile Drug Product), including real-time observation of activities, and monitor process operations to ensure compliance with specifications.
- Make quality decisions and escalate issues to management that may impact operations. Identify risks and communicate gaps in quality and GMP process/systems.
- Perform routine walkthroughs of manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise.
Your responsibilities will also include:
- Enforce adherence to cGMPs, SOPs, and manufacturing documentation.
- Partner with manufacturing and support teams to initiate and triage new deviation events, reviewing minor manufacturing deviations.
- Author and review documentation, including SOPs and Work Instructions, to ensure compliance with regulations and cGMP operations. Review executed electronic and paper batch record documentation.
- Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency.
- Operate on a shift structure.
The key Moderna Mindsets you’ll need to succeed in the role:
- We behave like owners: You will be expected to take full ownership of the quality oversight process, making decisions that directly impact manufacturing operations.
- We prioritize the platform over any single solution: Your focus will be on ensuring that the manufacturing process adheres to the highest quality standards, contributing to the overall success of Moderna's mRNA platform.
Here’s What You’ll Bring to the Table:
- Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience
- 3 – 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
- Sterile drug product manufacturing experienced preferred
- This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.