As an IT Quality Services Consultant for a client within the Medical Device industry, I am responsible for development, approval, and maintenance of computer system validation documentation (i.e. validation relevance/ERES assessments, user requirements, risk assessments, design/configuration, trace matrices, etc.). Additionally, I have been responsible for installation/operational qualification creation and execution and change control maintenance for the Siemens SIMATIC-IT Interspec, LabWare LIMS, Access Request Management, and Marketing Resource Management Systems.From September 2016 to November 2017, I successfully lead the validation effort for the upgrade of LabWare LIMS from version 5 to version 7 and was responsible for all validation deliverables.

Sequence, Inc. is a leader in providing validation and quality/compliance consulting services for industries regulated by the FDA. United with our Clients, we provide consumers with products of the highest quality. Through our knowledge, experience and integrity, we offer a level of service that is unsurpassed industry-wide.

-Perform system administration; provide technical and production support for SampleManager LIMS -Maintain validated state of quality laboratory computer systems-Assess specification changes and implement changes to ensure compliance with cGMP, corporate/site SOPs, 21 CFR Part 11, ICH guidelines

-Provided microbiological trending data from the LIMS for support of investigations and regulatory agency audits-Initiated investigations due to plant wide environmental monitoring deviations using Trackwise/CAPA system-Analysis of environmental data to complete product releases for aseptic and terminally sterilized productLIMS Upgrade/Implementation Project; Biological/Environmental Quality Subject Matter Expert (SME)December 2012-September 2014-Environmental Quality Configuration Lead; managed timelines and schedules-Process development/engineering-Data entry and verification -Development of environmental sampling site rationales and sampling schedules-Revision/creation of quality system SOPs and change control documents-Assisted document authors with and reviewed/approved Validation Lifecycle IQ/OQ/PQ Documents (User Requirements, Risk Assessment, System Design Specifications, etc.)-Validation protocol development, test execution

-Performed routine microbiological and pharmacological testing; including viable and non-viable monitoring of aseptic and terminally sterilized areas -Written and performance analysis of manufactured product and WFI/PURW system-Data collection and entry into LIMS, recorded results, maintained log books and data sheets -Knowledge and certification of PPE, cGMPs, corporate/site SOPs and FDA regulations