QC Analyst II-Microbial Control
Core
Perform microbiological testing for in-process, release, and stability samples to ensure drug product safety and quality.
Role type
QC Analyst II (Microbial Control)
Builds
In-process and final product samples for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Microbiology, aseptic techniques, cleanroom operations, data interpretation, deviation identification, GMP compliance, documentation, sample handling
Preferred skills
GMP laboratory experience, environmental monitoring, utility monitoring, HVAC sampling, trend analysis
Technologies
Laboratory systems, data recording software
Responsibilities
Perform microbiological testing for in-process, release, and stability samples; Support environmental and utility monitoring including HVAC and facility sampling; Review and document test results in accordance with GMP and data integrity standards; Identify deviations and support investigations when results fall outside expected ranges; Ensure compliance with cGMP, GDP, and data integrity requirements; Participate in routine lab activities including sample handling and documentation
Seniority
Mid-level, hands-on IC