Michelle Mader Email & Phone Number

Chaska, Minnesota

• Represent the microbiology lab as SME for all microbiology testing and environmental and water quality monitoring for customer and regulatory body audits• Analyze environmental monitoring data and authored quarterly trending reports• Perform OOS and nonconformance investigations and provide support for CAPA processes• Communicate cross-functionally through leading monthly trending meetings and participating in project teams• Supervise 5 microbiologists/laboratory technicians

Chaska, Minnesota

• Managed final product testing schedule for over 400 batches per year while maintaining 100% on-time rate• Trained and certified over 120 employees for cleanroom gowning certification• Assigned testing responsibilities to 7 microbiologists• Investigated environmental and personnel monitoring above limit excurstions• Performed all tasks related to Microbiologist I

Chaska, Minnesota

• Performed in-process, release, and raw material testing and review• Maintained gowning qualification throughout tenure• Executed weekly environmental monitoring for cleanrooms up to ISO 5/Grade A and water quality monitoring for 50+ water ports• Collaborated with senior microbiologist to improve sampling philosophy used for monitoring of the WFI system; including updates to associated methods and sampling plans

Rochester, Minnesota Area

• Performed DNA and RNA isolation, PCRs, and qRT-PCRs• Assisted with mouse husbandry in an aseptic environment• Harvested and organized mouse tissues• Responsible for general laboratory maintenance and maintaining a safe, clean work environment