Associate Business Systems Analyst - Software Validation

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.


Summary
Primary focus of job is quality, validation and verification activities supporting regulated software used by BioLife. Job includes defining systems scope and objectives based on both user needs and a good understanding of applicable business systems, SDLC, design control processes, and industry requirements. Works closely with application development group, validation group, and end users to design and validate new systems or modify existing systems.


Essential Duties and Responsibilities
Analyze business processes and write system documentation including user requirements, risk assessments, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements.


Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems.


Develop documentation and perform system testing, verification and validation. Review validation or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements.


Understand and follow appropriate SDLC, quality validation processes and application processes. Provides support to business function and IT concerning quality issues and ensures conformance to established performance requirements and procedures.


Own key tasks, require moderate direction, and handle moderately complex problems.


Stays current with federal, state, local and company-specific rules, regulations and practices.

Qualifications
Strong written and oral communication skills required.


Solid understanding of design control process, SDLC and V,V&T techniques required.


Demonstrated understanding of quality assurance in an FDA-regulated environment and 21 CFR Part 11.


Understanding of relational databases required.


Must be detailed oriented and be able to work in a team setting.


Effective organizational, technical and problem solving skills.


Bachelor's degree or relevant work experience in systems or business required.


2+ years experience working within the application systems or business environment.


As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V