Initially created a gap analysis for identifying needed SOPs and Work Instructions. Creating and organizing the Document Control department. Wrote various procedures and implemented the corresponding processes to be ISO 9001 compliant. Responsible for development and delivery of PAS Employee Training Program. Additional core responsibilities include, monitoring and archiving of personnel training files. Track personnel training activity completion including SOPs/courses and report training metrics on a timely basis to management. Assisting the PLC group of the parent company (CNP) in developing a change system to document changes to PLC programs.

(Placed at Synthes, Mezzovico Switzerland & West Palm Beach, Florida) Assigned to Develop and implement a remediation process for over 1000 DCO’s as a result of an audit. As part of the remediation process a DCO checklist and a Remediation Memos were created for each DCO. An evaluation was conducted on all issued DCOs to determine record conformance to established policies and procedures and compliance to applicable regulatory bodies’ requirements. Having a key role in this project, I trained Synthes employees in the use of and implemented this process. I also completed ¼ of those Checklist and Memos needed to complete this compliance issue. Florida site – assisting with the implementation of a Johnson & Johnson global polices. This includes identifying conflicts with separate work streams and creating DCO’s to resolve the documentation conflicts. The documents are being marked up and some documents are being created to fill identified gaps. Also part of a four person team to create and streamline the documentation process between separate sites