Sommer graduated from Eastern Washington University with a BS in Chemistry and a Forensic Chemistry option. She has 17 years of industry experience with a Contract Manufacturing Organization dealing with highly regulated systems, processes, and agencies. Sommer started as a scientist in the Quality Control Laboratory and quickly worked her way into supervisory and management roles where she was responsible for release testing of incoming materials and facility utilities, laboratory sample chain of custody, overall compliance for the QC department, and the facility’s stability program. Compliance responsibilities included oversight of training for QC personnel; acquisition, installation, and qualification of new instruments; maintenance and verification of qualified instruments; method verification and/or validation; environmental chambers; and process controls for systems and use. Additional experience/certification include fluent use of pharmaceutical compendia, ICH guidelines, and CFR; method verification/method validation; SAP ERP (super user); Human Error Reduction and Human Error Investigation Diagnostics (HER and HEID certification); investigations, corrective and preventative actions (CAPA); regulatory agency/government inspections, client audits and associated responses. Throughout her career, Sommer has gained knowledge and experience in equipment management, computer systems validation, inventory control, problem solving, and knows how to operate a facility within the boundaries of cGMP requirements.