Charles Nehoda

Experience

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  Boehringer Ingelheim

  Sept 2003 - Mar 2012

  Lead investigator for exceptions (laboratory, manufacturing, and validation) including risk assessment/analysis, root cause analysis, disposition recommendation, and CAPA implementation.• Served as a mentor and sponsor for investigations owned and driven by manufacturing, quality control, and other groups. • Served as a liaison for customers providing regular updates on quality issues related to active investigations.• Successfully managed special projects including a batch disposition project which resulted in record number of releases per month, as well as critical response teams for high profile and high impact events which required expedited assessment and completion. Show less Wrote and reviewed Master Production Records (MPRs) and processed revisions to MPRs, ensuring accuracy, completeness, and compliance with established written standard operating procedures (SOPs), and accordance with cGMP requirements. • Coordinated efforts with customers and regarding communicating changes and meeting production deadlines. Maintained MPR templates.• Designed and rewrote SOPs describing critical departmental job functions. Consistently met and exceeded throughput goals. Show less

  • Quality Systems Specialist II

    Sept 2006 - Mar 2012

  • Technical Writer

    Feb 2005 - Sept 2006

  • Documentation Auditor

    Sept 2003 - Feb 2005
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  Philips

  Apr 2012 - Oct 2012

  QA/RA Engineer III (CAPA)

  Performed initial evaluation of CAPA requests and collaborated with CAPA owners from associate to senior management level to investigate approved CAPAs. • Documented and/or facilitated the documentation of the investigation, risk assessment/analysis, root cause analysis, CAPA action recommendations and effectiveness checks, and presented findings to the executive management CAPA board. • Played a significant role in closure of backlogged safety related CAPAs and CAPA requests for inspection readiness. Show less

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  Thermo Fisher Scientific

  Oct 2012 - Dec 2017

  Quality Assurance Engineer 2

  Former Affymetrix/USB Site. Managed and executed aspects of all elements of the ISO 13485 and 21 CFR Part 820 compliant quality system. • Implemented culture change from RUO focused site to IVD focused site, via operator training and improved structure for event handling, involving operations, engineering, and QA representatives.• Identified need for and implemented defect awareness training program.• Eliminated company complaint backlog by addressing root causes to reduce complaint rates by approximately 50 percent.• Served as investigator, sponsor and approver of CAPA, NCMR and deviation investigations.• Utilized the CAPA Process to address a trend of quality excursions which was leveraged to close the trend of related investigations, enabling a focus toward making necessary improvements to the quality systems, processes and infrastructure.• Managed a multi-disciplinary change control process and risk management activities for commercialized products; provided guidance, reviewed and approved content of validation protocols and reports. • Shaped risk management planning and reporting for the site by generating a general plan and report format for events. As a result, more time and effort was directed to risk identification, assessment and mitigation planning.• Contributed to the new product introduction (NPI) process by serving as a core team member, participating in design reviews, and facilitating quality review boards. Authored and facilitated risk management and quality plans for new products from design phase through commercialization.• Provided front room and back room support during multiple regulatory, customer and registration audits, which yielded positive outcomes.• Completed ISO 13485 Lead Auditor Certification program; performed and managed multiple internal ISO 13485 audits and supplier audits as lead auditor. Developed revised supplier audit program which more heavily weighted supplier performance scorecards in determining audit frequency. Show less

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  Oakwood Labs

  Jan 2018 - now

  Senior Quality Engineer

  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. Show less