Description
PURPOSE AND SCOPE OF POSITION:
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.
REQUIRED QUALIFICATIONS
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.
PRIMARY RESPONSIBILITIES
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.
Additional Job Requirements:
None