Specialist II, Quality Systems/Compliance

• Dec 2017 - Present

Responsibilities include APRs, Investigations, Change Controls, CAPAs, e-checks, Risk Management, Quality Agreements, Supplier Quality Notices, PAI Readiness, Client interactions, Data Trending, SOP/Work Instruction/Protocol/Specification creation, review and/or approval, Batch Record review, Master Production Record review/approval, Quality Council, Management Review, Metrics, Training, and much more. Systems/software used: SAP, Veeva (eDMS), SharePoint, elm (eLMS), Success Factor, etc. Responsibilities include APRs, Investigations, Change Controls, CAPAs, e-checks, Risk Management, Quality Agreements, Supplier Quality Notices, PAI Readiness, Client interactions, Data Trending, SOP/Work Instruction/Protocol/Specification creation, review and/or approval, Batch Record review, Master Production Record review/approval, Quality Council, Management Review, Metrics, Training, and much more. Systems/software used: SAP, Veeva (eDMS), SharePoint, elm (eLMS), Success Factor, etc.

Senior Manager, Quality Systems

• Dec 2016 - Dec 2017

Manager, QA Compliance

• Mar 2014 - Dec 2017

My responsibilities include direct Management of 6 people/2 departments, indirect management of 4 additional people, Change Control review/approval, Annual Product Review compilation/approval, QC product release and stability data review/trend assessment, SOP revision/approval, Regulatory Inspections, Internal Audits, Compliance Certification statements, Investigations, CAPA completion/review/approval, CAPA effectiveness assessments, incoming raw material review/release, batch record review/disposition, Master Production Record review/approval, specification creation/review/approval, Test Method review/approval, compilation/review/assessment of metrics, training, mentoring, presenting to Senior Management and more.

QA Supervisor

• 2012 - Mar 2014

Senior QA Associate

• Jan 2009 - 2012

Supervisor, QA Incoming / In-Process

• 2007 - 2008