QC Scientist II - Microbiology
Core
Perform microbiological testing of raw materials, components, and finished oral solid dosage products to ensure compliance with GMP and support product release.
Role type
QC Scientist II (Microbiology)
Builds
Product quality and patient safety for pharmaceutical manufacturing operations
Domain
Pharmaceutical manufacturing / Microbiology
Required skills
Compendial microbiological testing, microbial identification (MALDI-TOF/MicroSeq), growth promotion testing, GMP compliance, laboratory troubleshooting, technical documentation, data review
Preferred skills
FDA/EMA regulatory guidance knowledge, quality investigations, CAPAs, LIMS, data analysis, technical writing, mentoring
Technologies
MALDI-TOF, MicroSeq, LIMS, Microsoft Office
Responsibilities
Perform and review microbiological testing for product release and stability, conduct microbial identification, support environmental monitoring testing, review laboratory data and author SOPs, troubleshoot laboratory issues and participate in investigations, collaborate with cross-functional teams and provide technical guidance
Seniority
Mid-level, hands-on IC