Spec 1, Quality Control

• 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.