Senior Specialist IT Quality

Job Description

• Working at Abbott At Abbott, you can do work that matters, grow
• learn, care for yourself and your family, be your true self
• live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives
• scientists. The Opportunity: The Senior Specialist - IT Quality provides quality oversight and compliance leadership for regulated data center facilities, utilities
• equipment supporting healthcare and GxP - relevant IT operations. This role ensures that data center physical infrastructure and supporting systems are operated, maintained
• controlled in compliance with applicable regulatory requirements, internal quality standards
• industry best practices. The position partners closely with Facilities Engineering, Data Center Operations, IT Infrastructure, Quality
• Safety teams to ensure inspection readiness, lifecycle control
• sustained reliability of critical data center environments. Primary Job Function Individual contributor with comprehensive knowledge in specific areas and performs quality assurance support /project work related to:
• Data center facilities, utilities, and equipment
• Compliance initiatives
• Validations
• Supplier Quality activities
• Internal / supplier audits CAPA system investigation, confirmation
• verification. What You’ll Work On: Facilities, Utilities
• Equipment: Ensure that data center facilities, utilities
• equipment comply with applicable regulatory, corporate
• quality requirements. Ensure appropriate qualifications, documentation
• change control for regulated facilities and infrastructure. Oversee commissioning, qualification
• requalification activities for data center infrastructure and equipment. Review and approve lifecycle documentation, including: Installation, operational
• performance qualification protocols Maintenance and calibration records Ensure infrastructure remains in a validated and compliant state throughout its operational lifecycle. Ensure production and process controls are established, implemented
• maintained for data center facilities, utilities
• equipment supporting regulated IT operations. Provide quality oversight and approval for changes impacting regulated data center facilities, utilities
• equipment. Quality Compliance Ensure facilities- and equipment-related documentation is complete, accurate
• inspection-ready. Review nonconformances, CAPA, deviations, incidents, excursions
• infrastructure-related events impacting environmental or system integrity. Ensure timely investigations, root cause analyses, CAPA development
• effectiveness checks. Support and participate in internal audits, supplier audits
• regulatory inspections involving data center infrastructure. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Perform work using standard methodologies, processes and tools to ensure IT Compliance. Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for assessing risk and applying risk-based approach strategies without compromising compliance. Perform Quality function related to process improvements, metrics collection and analysis
• adherence to defined Abbott practices. Create, review and approve quality documentation in support of quality activities. Establish project tasks and timelines and is held accountable to them. Identify potential process improvements. Minimum Requirements & Qualifications: Required Qualifications: 3+ years of experience in a regulated quality systems environment, preferably within: Healthcare, pharmaceutical, biotechnology
• medical device industries Data center operations, facilities engineering
• critical infrastructure support Demonstrated experience in facilities, utilities
• equipment qualification and compliance. Strong analytical, judgment
• consultative skills with the ability to work across Facilities, IT
• Quality organizations. Knowledge of regulations and standards that affect the health care industry. Minimum Education Required Bachelor’s degree or equivalent experience Position Accountability & Scope Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with both IT management and staff. Accountable for global compliance with IT policy and procedures that have specific responsibility in the area of quality, documentation and adherence to global regulations. Exercises significant latitude in determining objectives, methods
• solutions to maintain compliance. Decisions directly impact regulatory readiness, infrastructure reliability
• continuity of regulated IT services. Supervisory Responsibilities None. Misc: This is an onsite role at Abbott location in IL. This is not a remote role/opportunity. Apply Now Learn more about our health and wellness benefits
• provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott
• on Twitter @AbbottNews. The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Information Risk & Quality Assurance DIVISION: BTS Business Technology Services LOCATION: United States > Waukegan : J46 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf