QC Associate II: Microbiology & cGMP Testing

Moderna; Marlborough (MA); On-site; USD 63,200 - 100,900; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a candidate based at their Marlborough, MA site to support cGMP microbiology methods for QC raw materials, plasmid, drug substance, Stability, finished product testing for mRNA products, and environmental monitoring. The role includes non-testing projects such as document certification and biosafety cabinet cleaning and runs on a 10-hour shift.

The position requires a BS (or MS) in a relevant science with QC experience in a cGMP setting, plus strong troubleshooting, communication,

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.

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.

Skills

Troubleshooting

Scientific communication

Documentation

Database familiarity

Education

BS in a relevant scientific discipline

MS in a relevant scientific discipline

Tools

LIMS

SAP

LMS

Job description

Moderna seeks a candidate based at their Marlborough, MA site to support cGMP microbiology methods for QC raw materials, plasmid, drug substance, Stability, finished product testing for mRNA products, and environmental monitoring. The role includes non-testing projects such as document certification and biosafety cabinet cleaning and runs on a 10-hour shift.

The position requires a BS (or MS) in a relevant science with QC experience in a cGMP setting, plus strong troubleshooting, communication,