Overview As QC Microbiology Lead, you direct the Microbiology Laboratory's daily operations to ensure accurate test results and regulatory compliance. You collaborate with formulation, filling, validation, engineering, and packaging teams to support product quality. You guide staff, develop and approve SOPs, and drive timely testing and investigations. You will lead environmental monitoring, validation studies, and data analysis, shaping quality for patients and processes. This role offers impact across a global healthcare mission in a cutting-edge imaging environment.
Compensation / Benefits- competitive salary
- continued personal development
- diversity and inclusion
- accommodations for disabilities
- global team collaboration
- equal opportunity employer
Responsibilities- Plan, direct and supervise administrative activities of the QC Micro Lab
- Lead microbiology testing across raw materials, in-process, finished product, and environmental samples
- Perform and validate biological assays and validations (environmental monitoring, sterility, bioburden, endotoxin)
- Identify issues, lead investigations for out-of-spec results and instrument malfunctions
- Train and mentor staff; maintain SOPs and regulatory documents
- Prepare reports for investigations, APQRs, KPIs, QMRs, validations
- Coordinate testing schedules; serve on Kaizen/Lean Sigma teams to improve processes
- Maintain inventory of lab supplies and ensure audit readiness with regulatory agencies
- Support QA functions: OOS investigations, specification management, auditing
- Recordkeeping, data analysis, trend analysis, and use of LIMS where applicable
Key requirements- 5-6+ years hands-on pharmaceutical laboratory experience
- BS in Microbiology, Biology, or life sciences
- Experience with environmental monitoring, LAL testing, sterility testing, filtration, particulate testing
- Aseptic technique, cleanroom behavior, cGMPs, GLPs, FDA requirements
- Ability to train staff and communicate effectively with cross-functional teams
- Proficient in data analysis; able to perform calculations and trend analyses
- Knowledge of regulatory documentation and SOPs; audit readiness
- strong interpersonal and verbal/written communication
- team leadership and coaching
- problem solving and investigative mindset
- microbiology assays (growth promotion, sterility, bioburden, endotoxin, membrane filtration)
- environmental monitoring
- method development/validation
