100% Onsite!
Description
PURPOSE AND SCOPE OF POSITION:
The primary focus of the Systems Analyst will be to define, develop, deliver and support GMP e-systems, with primary emphasis on the Quality Control system LabWare LIMS, used in the Jump manufacturing plant in Bothell WA.
REQUIRED QUALIFICATIONS
- Education: Minimum Bachelor's 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, troubleshooting, 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 lead 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 a supportive and cooperative work environment.