Quality Control Associate, Microbiology
Core
Perform cGMP microbiology testing (Endotoxin, Sterility, Environmental Monitoring) to support the release and stability of innovative mRNA medicines.
Role type
Quality Control Associate (Microbiology)
Builds
Drug substances and drug products for mRNA therapies
Domain
Biopharma / mRNA manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP microbiology testing, Endotoxin testing, Sterility testing, Micro sequencing, Growth promotion, GxP compliance, Data integrity, Laboratory inventory management, OOS investigation support, CAPA participation
Preferred skills
Method qualification, FDA/EU/ICH guidelines knowledge, Cross-functional collaboration, Prior pharmaceutical QC experience
Technologies
LabVantage LIMS, Electronic Assay Forms
Responsibilities
Execute GMP QC Microbiology testing including Sterility, Endotoxin, and Micro sequencing; Support testing of drug substances and products; Perform data entry and trending in electronic systems; Manage laboratory inventory and supplies; Assist with troubleshooting assays and equipment; Participate in laboratory investigations, deviations, and CAPA activities; Maintain accurate cGMP documentation.
Seniority
Individual Contributor