Sr. Manager, Quality Assurance

• Jul 2017 - Present

Quality Engineering Manager

• Jan 2016 - Present

Manage Key Quality System processes. Function as Quality Engineering Manager for design R&D and Manufacturing process operations. Manage Key Quality System processes. Function as Quality Engineering Manager for design R&D and Manufacturing process operations.

Independent Consultant

• Jul 2012 - Jan 2016

Expertise in: -FDA and European submissions -Full life cycle compliance -Micro/Sterile validation -Quality Systems, FDA QSR, ISO 13485 and CMDCAS -Facility design and validation -Health & Safety complaince Expertise in: -FDA and European submissions -Full life cycle compliance -Micro/Sterile validation -Quality Systems, FDA QSR, ISO 13485 and CMDCAS -Facility design and validation -Health & Safety complaince

Acting VP of Quality Assurance

• Feb 2013 - Sep 2015

Overall responsibility for the company’s risk management department; specifically responsibility for accurate translation of customer input and specifications to the product and its related risk profiles. Act as Quality System owner and developer; ensuring proper and effective implementation during the company’s development and patent creation. Acting company management representative; specifically focused on early stage customer and investor relationship development. Overall responsibility for the company’s risk management department; specifically responsibility for accurate translation of customer input and specifications to the product and its related risk profiles. Act as Quality System owner and developer; ensuring proper and effective implementation during the company’s development and patent creation. Acting company management representative; specifically focused on early stage customer and investor relationship development.

Sr. Quality Manager

• Feb 2014 - Sep 2014

Managed Quality System and processes. Functioned as Quality Engineer for design R&D and Manufacturing process operations. Managed Quality System and processes. Functioned as Quality Engineer for design R&D and Manufacturing process operations.

Plant Quality Manager

• Sep 2011 - Jul 2012

Managed new product implementation into the QSM. Managed new and current product design controls and risk analyses. Managed all aspects of QA/QC for manufacturing. Acted as Management Representative for internal management reviews as well as external regulatory agency reviews. Acted as facilities and safety management officer working with local and national regulatory agencies. Managed new product implementation into the QSM. Managed new and current product design controls and risk analyses. Managed all aspects of QA/QC for manufacturing. Acted as Management Representative for internal management reviews as well as external regulatory agency reviews. Acted as facilities and safety management officer working with local and national regulatory agencies.

Director of Quality Assurance

• Jul 2004 - Apr 2012

QC Sup/Quality Engineer

• Mar 2001 - Jul 2004

Aseptic Manufacturing Tech, QA

• Mar 1997 - Jan 2001

Generic Paharmacuetical Manufacturing Generic Paharmacuetical Manufacturing