Scientist II (Microbiology)
Core
Perform routine and non-routine microbiological testing, environmental monitoring, and method validations to ensure product quality and compliance in a pharmaceutical manufacturing setting.
Role type
Mid-level Quality Control Microbiologist (Scientist II)
Builds
Production data for product release, validated test methods, and environmental compliance reports
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Microbiological test methods, cGMP/GLP compliance, SOP authoring and maintenance, root cause analysis, equipment calibration, aseptic technique, environmental monitoring, data integrity
Preferred skills
Training and mentoring analysts, project coordination, validation study design
Technologies
LIMS, KabiTrack, SKAN isolators, Gram staining, sub-culture
Responsibilities
Perform peer review of data for accuracy and conformance; Investigate nonconforming test results and environmental excursions; Develop and validate microbiological test methods; Train new personnel on SOPs and laboratory techniques; Maintain and calibrate laboratory equipment; Coordinate environmental monitoring and sampling activities
Seniority
Mid-level, hands-on IC with mentoring responsibilities