Develop websites with the team for clients. Responsible for continual maintenance of client website utilizing HTML5, CSS3 and Javascript. Constant uploading of time sensitive materials and promotions to site. Integrated text and imagery for microsites. Manage FTP server. Planning, organizing and leading weekly web design meetings. Interact with vendors weekly to assure timely completion of the tasks related to projects.  

Sr. QA Compliance Specialist. Provide QA oversight to submitted Change Controls to ensure that a complete impact assessment has been performed and all impacted processes and documents have been included in the action plan. Oversee change controls to ensure impact of the proposed changes are accurately interpreted, managed and applied. Responsible for administering the weekly change control meeting with the Local Change Board and Regulatory Affairs. Provide training and coaching to personnel on Kintana Change Control System. Work with other departments to proactively build quality into the processes and systems.

Responsible for completion of non-conformances, deviations and CAPAs. Developed and/or revised procedures for all departments during SAP implementation. Performed cGMP training to new hires. Actively participated in AABB and independent audits.

Coordinated all Validation activities associated with new Packaging Equipment and PCEs. Developed and executed Validation protocols. Developed Design of Experiment studies and Technical Reports on new Packaging Configuration. Developed PFMEA for Sealing Equipment.

Developed GMP (Good Manufacturing Practices) Manual and Quality standards Manual in accordance to QS 820 (Medical Device Regulations). Developed several protocols and proposals. Supervised Quality Control personnel. Responsible for CAPAs and SCARs. Responsible for external and internal QA audits and prepared audit reports.