• Performs microbiological testing on raw materials, in-process product, finished products, and stability samples according to applicable procedures.
• Collects environmental samples and perform analysis according to applicable site procedures.
• Maintain laboratory trending data.
• Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision.
• Perform equipment validations/verifications with minimal supervision.
• Execute test method validations as required.
• Performs assigned projects and tasks.
• Compiles testing data and review testing results.
• Maintains Microbiology Laboratory.
• Order supplies, reagents and materials as needed.
• Supports equipment maintenance and calibration activities.
• Understands lab safety and hazardous waste management.
• Cleans and maintains laboratory areas and equipment according to procedures.
• Supports investigations and implementation of corrective actions.
• Responsible for maintaining laboratory logbooks and records according to Good Documentation Practices.
• Performs Microbiology Lab activities as assigned by lab supervisor and/or Quality Manager/Designee in order to achieve QC testing delivery goals.
Maintains Microbiology Lab audit readiness.