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.
Qualifications
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.
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.
