Associate II, Quality Control

Moderna • Marlborough, MA

1d • $63,200 - $100,900 • Onsite

About The Position

Moderna is seeking a Candidate based at their Marlborough, MA site. The Individual will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability, finished product testing for mRNA products produced and Environmental and critical utilities monitoring at Moderna’s manufacturing facility. This individual will contribute to non-testing projects and activities as needed example document certification, monthly biosafety cabinet cleaning etc. This position will be working a 10-h Shift.

Requirements

• 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.

Responsibilities

• Execute compendial microbiological testing, and other methodologies as needed.
• Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, Culture Purity,
• Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.
• Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, Document Certification etc.
• Stock and perform inventory of lab supplies.
• Establish and maintain a safe laboratory working environment.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level