Amy Lewis

Managed multiple compliance-driven operational workstreams in a primarily remote environment, independently prioritizing deadlines, maintaining accurate records and reporting, and coordinating with internal and external stakeholders. Remediated a large backlog of disorganized records and established a structured record-management system.

Led QC Microbiology operations supporting FDA-regulated pharmaceutical manufacturing, with responsibility for quality-system activities, technical documentation, departmental priorities, and cross-functional manufacturing support. Participated in monthly Quality Management Review meetings and prepared PowerPoint materials on investigations and CAPAs.

Supervised QC Microbiology operations supporting pharmaceutical manufacturing, with substantial responsibility for quality systems, regulated documentation, technical review, investigations, and cross-functional problem solving. Supported quality metrics and management reporting and participated in cross-functional product-launch teams.

Performed advanced QC microbiology testing, technical investigations, method suitability, and validation activities supporting pharmaceutical manufacturing in accordance with cGMP requirements and USP standards. Maintained compliant technical documentation.

Performed microbiological testing of raw materials, finished products, stability samples, and environmental samples. Analyzed and documented results, performed peer review, and supported investigations of unexpected and out-of-specification results.

Supported QC Microbiology laboratory operations in an FDA-regulated pharmaceutical manufacturing environment, including sample and material preparation, testing support, accurate laboratory documentation, data review, and equipment activities.

Bachelor of Science in Microbiology from the University of Minnesota - Twin Cities.