Sr. Specialist QA

Abbott

7d • $68,000 - $136,000

About The Position

Sr. Specialist QA

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and 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 high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
The Sr. Specialist works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. The Quality professional is responsible for supporting the Analytical Quality Assurance (AQA) Laboratory through the preparation and authorship of Laboratory Investigation Reports (LIRs). Works daily with testing technicians and Technical Product Support to ensure accurate and compliant analytical testing. Executes platform quality testing within WWLIMS and SAP systems, ensuring data integrity and adherence to quality requirements. Provides timely input to support CAPA investigations and is responsible for owning and approving testing events as needed. Maintains product and testing inventory in compliance with the Quality System. Serves as a Quality Professional, performing daily activities independently with minimal supervision. Acts as a primary point of contact for laboratory issues. Provides technical input on testing processes and serves as a Subject Matter Expert (SME) within certified areas for Alinity s, Alinity i, and the ARCHITECT Platforms. May contribute testing redlines, support test method updates, support the on-market stability program, and lead/manage laboratory activities as required.

Requirements

• Bachelor's Degree or equivalent experience and demonstrated competence; additional post-graduate education may contribute toward the desired years of experience
• 2-3 years of related work experience with a good understanding of specified functional area
• Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures
• Demonstrated initiative and problem-solving skills; critical-thinking skills
• Strong organizational and project management skills

Nice To Haves

• Bachelor’s of Science Degree, Biology, Chemistry, Bio-Chemistry, Medtech, Med-Device Engineering
• Abbott Alinity Platform Knowledge
• LIR and CAPA Knowledge
• WWLIMS
• SAP
• Trackwise

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Interfacing with Planning, Demand Planning, Order Entry, Technical Product Support (TPS), Manufacturing Quality Assurance (MQA), and laboratory personnel for completion of AQA testing and stability studies.
• Reporting of metrics to site and division management.
• Additional assignments from lab manager and supervisor as needed to support production which can include authoring/approving LIRs, approving NCRs, initiating/approving Change Requests, initiating/approving Design Plans etc...
• Responsible for assisting in the implementation and maintenance of an effective Quality System for the Lake County site.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Independently contribute to Quality System processes which may include training, corrective and preventative action activities (CAPA), quality audits, validation, equipment maintenance, product and process planning.
• Responsible for independently completing documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures and guidelines.

Benefits

• 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 high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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