ITS Software Quality Analyst

Terumo BCT, Inc. • Lakewood, IL

9d • $91,600 - $114,600 • Onsite

About The Position

Works under general supervision by providing technical expertise in an area of software validation activities to include testing. Performs a range of tasks which may include analysis, evaluation, testing, and documentation.

Requirements

• Bachelor’s degree in computer science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Minimum 2 years of experience
• Experience in validation of ERP, QMS/PLM, HRIS and CRM preferred.
• Requires flexibility to adapt to and a willingness to learn new technologies.
• Familiarity with GMP/GAMP V/IEEE/ISO 9000 standards for software quality assurance, impact/risk analysis, and software traceability.
• Strong with documentation; writing sound user and functional requirements documents, validation summary reports, validation test scripts and deviation documents
• Demonstrate a strong voice in group settings to maintain program integrity
• Must be able to manage deadlines
• Must be very detail oriented in following all aspects of the validation program and ensuring all completed validation packages are audit ready. This is a key to success
• Capability to implement a process discipline and maintain departmental productivity.
• Ability to perform business analyst duties to assist with requirements gathering responsibilities is a plus
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge in applicable regulatory life science regulations (FDA CFR Part 11)
• An equivalent competency level acquired through a variation of these qualifications may be considered.

Responsibilities

• Operates somewhat independently in executing validation testing and documentation activities per the program policy and procedure for the company Quality Management System and Product Lifecycle Management Systems.
• Develops user requirements/functional requirements, test plans, test procedures, and test scripts based on system and software requirements.
• Become well versed in testing global enterprise applications for SAP ERP, QMS/PLM Windchill, SAP Successfactors and CRM Salesforce/ServiceMax.
• Work with team members to deliver on time validated software code to production.
• Requires demonstrated ability to analyze problems of varying levels and then design and implement solutions.

Benefits

• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• 401(k) plan with a matching contribution
• vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level