Job Snapshot
Location:
Santa Ana, CA 92705
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Industry:
Biotechnology
Medical Equipment
Job Type:
Engineering
QA - Quality Control
Experience:
At least 5 year(s)
Contact Information
Description
At Abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. Today, 72,000 Abbott employees are doing work that matters.
Addresses high risk observations from Abbott gap assessment with regards to validation of AMO software tools.
- Provides IT support to validated systems for plannned and unplanned projects.
- Responsible for compliance with applicable Corporate and Divisional policies and procedures.
- Provide software validation and compliance support to AMO critical systems (SAP, Agile, CATSWeb, LMS, etc.)
- Day to day IT support for software compliance and validation efforts of existing and new systems.
- Assures compliance of computer related systems with minimal to no delays due to QA resource constraints.
- Writes/reviews validation documentation for GxP systems.
- Review/approve Remedy change controls for IT.
- Supports annual Infrastructure changes and disaster recovery activities.
- Performs software supplier audits.
- Maintains and updates as necessary procedures related to the SDLC (Software Development Life Cycle) process.
QUALIFICATIONS:
Basic Qualifications:
Minimum 6 years experience in a medical device regulated industry. MS Office Suite, Agile and SAP, Client/Server, Web-based applications. Knowledge of FDA/GMP/ISO requirements and regulations. Ability to write software validation protocols. Familiar with SDLC process. Knowledge of database: MS Access, SQL Server, Oracle. Experience with software auditing.
Preferred Qualifications:
Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference. Through our diverse healthcare businesses, we connect people and potential in ways that no other company can.
Discover a world of opportunities at Abbott.
 EEO Statement:
At Abbott, we believe that diversity drives innovation. Innovative thinkers who are passionate about the work they do, Abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.
