Charles Nehoda

Senior Quality Engineer @Oakwood Labs

Solon, OH, US

Managed and executed aspects of all elements of the 21 CFR Parts 210 and 211 compliant quality system for injectable pharmaceutical products. • Project managed, authored and closed multiple Phase II (full-scale) investigations, including high visibility, business critical events. • Performed training and mentoring of other employee’s investigation writing. • Worked with exceptions (deviation, investigation, and CAPA) owners to improve content. • QA reviewer/approver of majority of exceptions. • QA reviewer/approver of document and process change controls. • Served as quality liaison for Business/Quality meetings of largest commercial client. • Authored Continued Process Verification (CPV) and Annual Product Review (APR) reports. • Identified the need for, convened, and lead multiple multi-disciplinary risk assessment teams, including facilitation of risk assessment process and authoring or approval of final reports. Substantially improved equipment cleaning process risk portfolio. • Started CAPA review board and hosted/facilitated monthly CAPA review board meetings. • Created and/or assisted in creating projects in Project Management System (Hive) for CAPAs in response to business need and to support compliance goals. • Trained new Quality Systems resources. • Supported changing business needs, including supply challenges and multiple new product introduction projects. • Served as lead auditor for internal and external (supplier) audits. • Prepared content for and hosted/facilitated Management Review meetings. • Drove meaningful, value-added process improvements through the CAPA program. • Supported client audits in both front-room and back-room. • Managed multiple projects to completion to meet due dates and commitments to clients.

Cuyahoga Community College

Coursework

Cleveland State University

Bachelor of Science - BS