Senior Specialist IT Quality

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 and FreeU education benefit - an affordable and convenient path to getting a bachelors 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 and scientists.

The Opportunity:

The Senior Specialist - IT Quality provides quality oversight and compliance leadership for regulated data center facilities utilities and equipment supporting healthcare and GxP-relevant IT operations. This role ensures that data center physical infrastructure and supporting systems are operated maintained and controlled in compliance with applicable regulatory requirements internal quality standards and industry best practices.

The position partners closely with Facilities Engineering Data Center Operations IT Infrastructure Quality and Safety teams to ensure inspection readiness lifecycle control and 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 or verification.

What Youll Work On:

Facilities Utilities and Equipment:

• Ensure that data center facilities utilities and equipment comply with applicable regulatory corporate and quality requirements.
• Ensure appropriate qualifications documentation and change control for regulated facilities and infrastructure.

• Oversee commissioning qualification and requalification activities for data center infrastructure and equipment.
• Review and approve lifecycle documentation including:
  • Installation operational and 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 and maintained for data center facilities utilities and equipment supporting regulated IT operations.

• Provide quality oversight and approval for changes impacting regulated data center facilities utilities or equipment.

Quality Compliance

• Ensure facilities- and equipment-related documentation is complete accurate and inspection-ready.
• Review nonconformances CAPA deviations incidents excursions and infrastructure-related events impacting environmental or system integrity.
• Ensure timely investigations root cause analyses CAPA development and effectiveness checks.

• Support and participate in internal audits supplier audits and 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 and 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 or medical device industries
  • Data center operations facilities engineering or critical infrastructure support
• Demonstrated experience in facilities utilities or equipment qualification and compliance.
• Strong analytical judgment and consultative skills with the ability to work across Facilities IT and Quality organizations.
• Knowledge of regulations and standards that affect the health care industry.

Minimum Education Required

• Bachelors 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 and solutions to maintain compliance.
• Decisions directly impact regulatory readiness infrastructure reliability and 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.

• Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
• 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 on Facebook at and on Twitter @AbbottNews.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

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MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

Senior IC