QC Microbiology, Analyst I

Job Responsibilities:

• Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
• Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.
• Author/update laboratory procedures, protocols, and help in EM data trend reports.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.
• Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.

Skills:

• Excellent knowledge of Aseptic technique and common microbiological testing
• Knowledge of relevant, compliance and guidance documents
• Must be able to gown into cleanrooms in support of testing and manufacturing activities
• Good documentation (ALCOA +) and data organization
• Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.
• Interpersonal skills and ability to contribute to the success of a team

Education/Experience:

• B.S. degree in Biology/ or other life science related degree with 0-3 years of relevant industry experience in a quality control role.