Dennis Berger

Dennis Berger has three years of work experience. In 2022, they began working as a Computer System Validation (CSV) Consultant for Pinnaql. In this role, they authored and updated laboratory instrument, process, and validation SOPs, developed computer system validation documents to facilitate process improvements for laboratory instruments to be FDA 21 CFR Part 11 and GxP compliant, and executed validation protocols and prepared reports. From 2019 to 2021, they worked at Datwyler Sealing Solutions as a Quality Control Team Lead and Quality Control Laboratory Technician. As a Team Lead, they supervised, developed, and motivated QC team members, authored and/or reviewed electronic batch records, change control requests, SOPs, WIs, and other quality related documents, and supported internal audits and regulatory lab inspections. As a Technician, they trained new QC Technicians on procedures and basic laboratory practices/techniques, documented and executed detailed test plans, investigations, and summarized audit findings for reporting purposes, and inspected finished products and raw materials to verify quality. Finally, in 2018, they worked as a Rehabilitation Technician for NovaCare Rehabilitation. In this role, they observed and recorded patient responses to therapies and exercises to report to PT/OT, assisted in developing care plans for patients with complex needs, and maintained a clean and safe work area, as standardized in departmental policies and procedures.

Dennis Berger obtained a Bachelor of Science from the University of Delaware in Biomedical Sciences from 2014 to 2019. Dennis then pursued a Master of Business Administration from Wilmington University from 2020 to 2022, with a focus on Business Administration, Management and Operations. In addition, they obtained a ISO 9001:2015 Internal Auditor Exam from BSI in May 2022, as well as a ISO 9001:2015 Internal Auditor Training Course from BSI in April 2022.