• Responsible for investigating/ debugging and resolving application issue

• Implementation of configuration changes

• Perform risk analysis, solution design and solution development

• Analyzing system updates and installing release and patching updates required to keep system up to date

• Working with other business leads on coordinating and implementing server upgrade for our Development, Test, Post Production and Production environments.

• LIMS basic and HTML code development and testing

• Developing and troubleshooting system components in order to maximum performance.

• Provide technical expertise regarding several different interfaces

• Conducted performance testing, multi-user testing and regression testing

• Processed client requests for changes and enhancements to the system including new workflows, better performance, new functionality among others.

4 years of LIMS experience. 2.5 years of LabWare experience

Served on a global project as a business analyst. Worked with business and Labware developers on implementation.

Experience with analysis, product, sample plan, standard reagent, instrument configuration.

Experience with developing and reviewing training manuals on custom configuration for end users.

Experience developing stability protocols within Labware.

Configuring and validating Laboratory Information Management Systems (LIMS), such as LabWare / LabVantage SQL LIMS.

o Developing validation master plans and validating LIMS implementations

o Validating custom configurations, including database tables and reports, custom queries and laboratory instrument interfaces.

o Configuring and validating LIMS for QC (GMP) and Clinical (GLP/GCP) laboratories.

• Direct and conduct analysis of requirements and programs in the data system

• Developing and maintaining lifecycle documentation, including user requirement specifications, functional specifications, risk assessments, and traceability matrices.

• Provide technical guidance and advice on the most appropriate method or procedure of analysis, testing and evaluation to accomplish missions.

• Provide guidance on fast alternatives when resolving user issues

• Developing, maintaining and updating security controls and procedures to insure database integrity.

• Developing and troubleshooting system components in order to maximum performance.

• Perform analysis of self workload on assigned tasks to provide estimates of man-hours needed for design, code, testing, validation, documentation and implementation.

• Provide information, advice and possible alternative courses of action when resolving new or existing problems.

• Communicate effectively with programming, technical and support staff, concerning results of project development and lifecycle.

Member of a global project team to develop, implement, and validate a data collection and management database, LIMS. Acted as a member in a three phase implementation of the new global lab data collection system

Phase I - Collect, Clean and Build

Assisted in the development/build of analyses, product specifications and sampling plans in accordance with all applicable quality approved documents

Assisted in the development of complex LIMS Basic routines, complex calculations and queries.

Developed work aids and training material to aid users in navigation of the LIMS system.

Phase II - Verification

Trained the business users during the verification process.

Performed data migration from the initial build environment into the verification environment.

Performed boundary testing on complex calculations at extreme conditions to prove the calculation's logic had been configured correctly.

Constructed demos to display the usability of the system to business users.

Phase III - Implementation

Provided LIMS technical support to Quality Control, Production and Batch Release personnel.

Supported the creation, validation and maintenance of reports, calculations, queries.

Performed the following assays:

• Sodium Citrate and Sodium Chloride Titration

• Moisture Determination by TGA analyzer

• O-Acetyl Determination

• Protein Determination by Lowry and Bradford procedure

• Determination of Iron, Fiske-Subbarow Method for Phosphorus

• Determination of Total and Free Hydrazide in Meningococcal Derivitized Polysaccharides

• Colorimetric Sialic Acid Determination for Total Sialic Acid Determination of Free Polysaccharide in Meningococcal Polysaccharide/Toxoid Conjugates and Intermediates