neil carolan

* Led the Protein Chemistry Group developing bio-conjugates and solid phases for immunoassays. * Presented relevant documentation for internal management and external customers. * Developed a method for the isolation of a hormone by HPLC Analysis. * Mentored team members to further their training, expand their knowledge base.

* Provided technical support to products during manufacturing, in-process testing, and on market stability performance. * Completed the transfer and validation of products and manufacturing processes from a sister site. * Used Lean Six Sigma tools to standardise and improve efficiency in manufacturing and testing of products. Used statistical process charts to analyse critical parameters of manufacturing and stability. * Initiating associated document change control procedures whilst ensuring that all regulatory requirements were achieved. * Investigation of a field action by root cause analysis of issue and implement corrective actions. Reporting to stakeholders and reporting to regulatory body.

* Communicated to stakeholders project updates, budgets and routine queries. * Performed & participated in client and regulatory organisations auditing. * Established a stability study for an antitoxin product. * Developed and implemented GMP batch release assays for clients. * Introduced a statistical process control system to improve the performance of an assay. * Performed documentation reviews as part of the quality system. * Prepared health and safety risk assessments for biological materials.

* Perform validation testing of software applications developed. * Develop and maintain test documentation (Test plans, test cases, test exit reports). * Validation of websites constructed for the communication of environmental data with the public. * Defect management (root cause analysis, reporting confirmation testing of resolution). * Direct end user testing of products to ensure that requirements are met. Acting as a liaison to resolve issues encountered during their testing and to communicate updates. * Supporting end users (internal & external users) resolve issues encountered when using software.

The traditional approach to experimental design is to use what is known as OFAT (one-factor-at-a-time). This method of experimentation has been shown to be highly inefficient and importantly often fails to identify often important interactions among factors. Design of experimentation (DOE) is a highly advanced analytical tool based on statistical techniques which uses devoted computer software to assist in the design of multi-factorial experiments. In essence DOE uses a minimum number of experiments to obtain the maximum return of information.

Learned the concept and methodologies of Lean Six Sigma and the DMAIC approach to process improvement. Developed an understanding of the tools involved in the individual phases of the Methodology. Learned how to use of the tools in characterising a process, analysing process data, improving and then controlling processes. Learned how to use a statistics software package that is used to analyse data