Associate Director Quality Assurance

• Mar 2021 - Present

Sr. Manager of Training and Compliance

• Oct 2019 - Jan 2021

• Management of Client Audits and Audit Responses • Site Internal Auditor, reviewing all departments on a 2 year cycle • Monitor and review all cGMP processes on the manufacturing floor across site, including aseptic production • Served as Project Manager for various process improvements initiatives – including CAPA program • Creation and implementation of CAPAs • Management of the Audit CAPA program and personnel within the compliance team • Applied expertise on US FDA cGMP and GDP standards to ensure quality and guide staff • Enforced regulations from FDA 21CFR 820, 210/211, ICH and ISO 9001:2008 guidelines • Project Lead for practical training program re-development • Document revision and creations for Forms, SOPs, Project Documents • Quality Event identification and investigation in CaWeb • Leader for audit preparedness for general processes, support systems, and facilities Show less

Quality Assurance Specialist, OTF

• Jun 2017 - Oct 2019

• Quality Assurance professional, monitoring floor activities, providing insight to improvements, and ensuring proper cGMP compliance. • Monitor and review all cGMP processes on the manufacturing floor across site, including aseptic production • Real-Time and Post Process Batch record review for bulk and filled media products • QA Release of records as needed • Inspection of discards, rejects, and products from line • Applied expertise on US FDA cGMP and GDP standards to ensure quality and guide staff • Enforced regulations from FDA 21CFR 820, 210/211, ICH and ISO 9001:2008 guidelines • Supplemental project team lead and member in multiple site-wide process improvement projects • Designed and executed projects with >$250,000 in savings annually • Document revision and creations for Forms, SOPs, Project Documents, and Batch Records • Deviation identification and investigation in Trackwise • CAPA and Effectiveness Check creation and implementation via Trackwise and change control system • Project Lead for Audit Preparedness for general processes, support systems, and facilities • External Audit team member, reviewing vendor processes for cGMP compliance Show less

Sr. Qualty Specialist (Consultant)

• Apr 2016 - Feb 2017

• IVD Label inspection of over 200 individual components and kits • Audited quality control, production, and environmental systems • IVD Batch record review for reagents and sub-components • Provided support to CAPAs, Non-Conformances, and Deviations • Raw-material inspection, release, and labeling • Applied expertise on US FDA cGMP and GDP standards to ensure quality • Trained-in and utilized Agile document management, Trackwise, and E1 ERP systems • IVD Label inspection of over 200 individual components and kits • Audited quality control, production, and environmental systems • IVD Batch record review for reagents and sub-components • Provided support to CAPAs, Non-Conformances, and Deviations • Raw-material inspection, release, and labeling • Applied expertise on US FDA cGMP and GDP standards to ensure quality • Trained-in and utilized Agile document management, Trackwise, and E1 ERP systems

Quality Engineer (Contract)

• Dec 2015 - Mar 2016

• Inspection of various mechanical, welded and formed parts • Assignment of task for quality support roles • Testing of equipment from customer returns and defect investigations • Applied expertise on US FDA cGMP and GDP standards to ensure quality • Enforcement of US FDA operations standards (21CFR 801, 803, 820) • Developing knowledge of Oakworks, Inc. products and processes • Calibration, reliability and repeatability studies of various measuring equipment • Administration of Non-Conformance Reports and departmental coordination of their investigation Show less

SolidManufacturing Supervisor

• Mar 2015 - Nov 2015

•Supervision of staff in processing, compression, and packaging areas of plant •Review of batch records for proficiency and quality assurance •GMP and GDP training to Johnson & Johnson-McNeil standards •Trained in Johnson & Johnson management tools and applications •Developed knowledge of McNeil’s process, methodologies, equipment, and organization •Implemented an inclusive, learning driven approach to shift leadership •Communicate shift objectives, successes, delays, and solutions to reporting staff and management team •Responsibly manage successful completion of weekend objectives across many areas with a diverse team •Management of materials in SAP Show less

Research Analyst

• Jun 2014 - Dec 2014

-Collect, Process, and Analyze satisfaction and engagement research -Run significance testing including but not limited to Mann-Whitney, T-test, Regressions, and ANOVAs -Assist project managers in defining scope of project and collection methodology -Create complex reports that disseminate all data collected and tested in an easy to understand manner -Build professional and detailed executive summaries of project results -Utilize Access for project management organization as needed -Conduct all test and report building IBM SPSS and MS Excel Show less

Director Of Operations (Contract)

• Nov 2013 - Mar 2014

Manager of day to day operations for Quest Behavioral Health: -Supervising the Members Call Center and IT Department -Analysis of operations, work-flow planning, resource allocation -Project Management, data analysis, reporting -Strategic, analysis based decision making -Ensuring compliance of Quest with all applicable laws, policies, and contractual obligations -Coordination with clinical team to ensure optimal service -Providing the primary point of contact for each partner/owner -Legal research -Presenting operational plans to management and employees Show less

Sales Assistant

• Jul 2013 - Oct 2013

-Business to business sales, customer service, & networking -Order processing -Process input & coordination -Proof-reading, editing, technical & professional writing of marketing materials -Business to business sales, customer service, & networking -Order processing -Process input & coordination -Proof-reading, editing, technical & professional writing of marketing materials