Our client, a leading pharmaceutical company, is hiring a Business or Systems Analyst consultant on a contract basis.
The primary focus of the Systems Analyst will be to define, develop, deliver and support GMP e-systems, primary emphasis on the Quality Control system LabWare LIMS, used in the Jump manufacturing plant in Bothell WA.
• Education: Minimum Bachelors degree in a technology or relevant scientific discipline required
• 3+ years of experience in IT and/or QC at life sciences (biopharmaceutical preferred) organizations supporting plant-based GMP applications.
• Proven expertise implementing and supporting quality control applications such as laboratory information system (LIMS).
• Strong understanding of laboratory business processes as well as software development lifecycle.
• Experience developing in LabWare LIMS basic desired.
• Experience developing queries and reports using T-SQL desired.
• Experience developing reports using Crystal Reports desired.
• Experience involving systems integration.
• LabWare Admin I certification is preferred.
• Excellent critical thinking, trouble shooting, and collaborative, written and verbal communication skills are required, as is attention to detail and the ability to work within a multi-tasking environment.
• Demonstrated success working in a high-performing, business results-driven environment.
• Drive collaboration between the Quality, Manufacturing, Supply Chain, Facilities and Tech Transfer departments, developing business justification for new capabilities, capturing and documenting detailed requirements; providing input on design and implementation strategy.
• Actively participate and leads all phases of application/system integration implementation, including the ownership of key deliverables such as User Requirements Specifications, Function Specification, Design Specifications and test cases.
• Participate in GMP validation activities including the development and execution of IQ/OQ/PQ testing.
• Provide technical support of LIMS in their production use.
• Oversee and/or perform application administration duties for systems such as the laboratory information system (LIMS).
• Assure quality customer service to all customers, promote positive service relationships, and contribute to supportive and cooperative work environment.