Associate II, Quality Control
$63,200–$100,900 year
On-siteMarlborough, Massachusetts, United States or Quality, Georgia, United States
Job Summary
Execute compendial microbiological testing for cGMP raw material, plasmid, drug substance, and finished product stability, including Endotoxin, Bioburden, and Environmental Monitoring. Support in-process samples and generate testing data to advance clinical studies while maintaining general laboratory operational systems. Perform daily tasks such as reagent preparation, equipment maintenance, BSC cleaning, and document certification to ensure a safe working environment. Work a 10-hour shift at Moderna's Marlborough, MA manufacturing facility, contributing to the development of mRNA medicines for serious diseases.
Required Qualifications
- BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year)
- Quality Control experience in a cGMP organization
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)
- Strong written and oral communication skills as well as organizational skills
- Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Must be based at the Marlborough, MA site
- Must be able to work a 10-h Shift
- Must be a U.S. person (citizen, permanent resident, asylee, or refugee)
- Must qualify as a U.S. person to access export-controlled information in accordance with U.S. law
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