Quality Assurance Engineer

JOSHUA S. SEBELIUS

**************@*****.*** I 314-***-**** I linkedin.com/in/joshua-sebelius-86776032 PROCESS ENGINEER

Process Engineer Oral Solid Dose/Sterile Injectables/Liquids Pastes • Pharmaceutical Manufacturing/Packaging Support 10 Years in Progressive Roles • Expertise in Pharmaceutical Process Development, Standardization, Equipment, Systems, GMP Documentation, and Cross Functional Leadership • Results Oriented Leader, Self starter, Analytical Thinker, Interpersonal Communicator, Problem Solver, Highly Productive Team Player

Product Launch / Re Launch to Market Tablet Manufacturing & Packaging Support Root Cause Investigations Six Sigma

Project Management FDA / EU Regulations

CAPA Customer Relations

Quality System Design / Improvement Environmental Monitoring Sterile Operations GMP Documentation Design and Implementation Customer Complaint Investigations Process Development / Improvement Microsoft Office, Excel, Lotus Notes, Microsoft Outlook Sterile Manufacturing Human Injectables Ennov, Compliance Wire, Minitab PROFESSIONAL EXPERIENCE

Virbac Animal Health: Bridgeton, MO 2013–Present

Manufacturer and Distributor of Animal Health Products Process Engineer 2015–Present

Quality Assurance Auditor/Engineer III 2013 2015

Promoted rapidly to Process Engineer based on strong cross functional teamwork, process improvements, tablet manufacturing/packaging engineering support, substantial deviation reductions, corrective & preventative actions, GMP documentation design/improvement/training/implementation. Notable Achievements:

Led a project team of 7 consultants that eliminated a backlog of 120+ manufacturing deviations while maintaining substantial volume of incoming deviations to support product release.

Led a project team of up to 9 consultants that eliminated a backlog of 3,200+ customer complaints in a 5 month period.

Designed new, or improved existing GMP manufacturing documents to streamline granulation, final blend, compression, and packaging processes to reduce deviations; i.e. batch records, process work instructions, SOPs.

Identified strategic equipment needs to support critical re launch and ongoing production of legacy Iverhart Plus® and Iverhart Max® product lines.

Completed Six Sigma black belt project to reduce variation of Sentinel® chew length from 15% to <5% in order to fit in previously approved blister well sizes. This prevented Virbac from purchasing new tooling and equipment requiring re validation activities/approval, as well as providing a substantial cost and time savings to support the new product launch budget and timeline. Legacy Pharmaceutical Packaging: Earth City, MO 2013 Contract Pharmaceutical Packager

Quality Assurance Specialist JUN 2013–OCT 2013

Quality Assurance Inspector JAN 2013–JUN 2013

Promoted rapidly to QA Specialist based on strong tablet packaging QA support, cross functional teamwork, root cause investigations, and corrective & preventative actions. Notable Achievements:

Independently eliminated backlog of 80+ customer complaints in 3 month period.

Cross functional team leader for complaint and deviation investigation resolution.

Improved company/customer relationships via complaint communications & resolution. Pfizer (Meridian Medical Technologies): Brentwood, MO 2007–2012 Human Injectables and Auto Injector Manufacturer

QA Environmental Technician

Responsible for the oversight and daily management of all Environmental Monitoring and Quality Assurance activities in the Aseptic Manufacturing Area. Notable Achievements:

Team Lead for Environmental Compliance Department.

Conducted training for all new hires in the Environmental Compliance Department.

Conducted all environmental laboratory testing to support manufacturing operations.

Cross functional team lead for process/equipment improvements in the Aseptic Manufacturing Area.

Presented suggested statistical and process enhancement/changes to Executive Team.

Develop GMP documentation improvement/implementation.

Received the Pfizer Employee Recognition Award from Senior Director of Quality for several achievements related to inventory in the Aseptic Manufacturing Area following a malfunction in the HVAC system. Several proactive steps were taken to prevent $800k+ in manufactured Epipen lots from rejection.

Recipient of the Pfizer Safety Award.

EDUCATION / CERTIFICATIONS

Bachelor of Business Administration • Fontbonne University, Clayton, MO Eckelkamp School of Global Business

Associate in Applied Science- Dietetics • St. Louis Community College, St. Louis, MO Six Sigma Black Belt Certification (CSSBB) • ASQ, • Certification Exam Scheduled Fall 2017

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