lia shields

* Perform gap analysis of business processes, SOPs and FDA regulations * Recommend changes to SOPs and Safety Procedures as needed to ensure compliance with FDA regulations and harmonize operations across multiple sites in PA and NC * Develop new SOPs for implementation of new work-order tracking system for Facilities Engineering * Perform requirements gathering, translating business requirements into technical specifications * Develop Functional Requirements Specifications for validation of the Integrated Control Systems at both the UP and UM sites.

* Maintained up to date knowledge on all systems-related regulations pertaining to pharmaceutical manufacturing (21 CFR Part 11, cGMP) in order to advise senior management on systems related decisions * Developed and documented new business processes * Initiated and implemented Change Controls as needed. * Perform gap analysis of business processes, SOPs and FDA regulations, including Part 11, and cGMPs * Developed new SOPs as needed * Assisted in administration of SQL LIMS and Turbochrom * Developed and implemented tracking system for SQL LIMS and Turbochrom update requests and adhoc report requests * Developed and validated adhoc reports using BRIO Query in support of Annual Product Reviews, FDA and Internal Audits * Developed, documented, coordinated and executed IQ/OQ/PQ validation plans for all systems at facility * Developed and implemented internal auditing system for laboratory USP binders ensuring compliance with FDA regulations * Cross-trained to assist with maintaining Master Batch Records for the production of sterile injectable products

* Developed and validated adhoc reports using BRIO Query and SQL * Developed and implemented documentation tracking system to decrease audit exposure * Perform requirements gathering, translating business requirements into technical specifications for both adhoc and system reports through participation on cross-functional project teams * Assisted with IQ/OQ/PQ testing of system releases * Researched and proposed strategy for Database Change Requests * Strategized and validated all data conversion efforts, for global system implementations * Train and mentor team members.

Prepared bioanalytical reports and compiled laboratory data Reviewed bioanalytical reports submitted by third party vendors for accuracy and compliance with BMS documentation requirements

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 74,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Chemistry Scholarship Bob Landholt Award for Excellence in the Laboratory Activities and Societies: Tutored Math, Physics, Chemistry

Combined degree program with stringent GPA requirements for admission, earned BS and MS simultaneously. Activities and Societies: Chemistry and Physics Lab Instructor at Burlington County College while a student at Drexel