Senior Specialist Quality Assurance- Biochemistry

Abbott Laboratories; Illinois; On-site; USD 87,000 - 173,000; Full time

Job summary

Abbott Laboratories, based in Abbott Park, IL, seeks a Senior Specialist Quality Assurance - Biochemistry to lead QA initiatives, ensure regulatory compliance, and drive risk management across cross-functional teams.

The role involves supporting Design Control, Change Management, and validation activities while mentoring quality professionals to uphold QC standards and product quality throughout the lifecycle.

Qualifications

• Bachelor's degree in Life Science, Engineering, or closely related discipline or equivalent experience.
• Minimum 5 years in quality or related field experience; advanced degree may reduce experience need.
• Master's degree preferred; supervisory experience is a plus; knowledge of diagnostic product manufacturing advantageous.

Responsibilities

• Maintain and enhance Quality System effectiveness, ensuring regulatory compliance.
• Lead and manage quality-focused projects with clear objectives, milestones, and timelines.
• Provide compliant solutions to complex quality and operational challenges aligned with goals.
• Identify, address, and escalate nonconformance issues to ensure QA compliance.
• Conduct risk assessments and develop risk management documentation for product/process risks.
• Investigate and resolve complex product testing issues with thorough analysis and corrective actions.
• Support Design Control and Change Management processes with impact assessments.
• Serve as a Quality Engineering leader driving initiatives from development through launch.
• Act as SME for validation activities and provide guidance on validation compliance.
• Mentor and train quality professionals, influencing project direction and promoting excellence across the organization.

Skills

Quality Assurance

Regulatory compliance

Risk assessment

Quality systems

Cross-functional collaboration

Validation activities

Test method optimization

Audit readiness

Education

Bachelor's degree in Life Science, Engineering, or closely related discipline

Equivalent combination of education and work experience

Master's degree (preferred)

Tools

Mass spectrometry

UV-Vis spectroscopy

Infrared spectroscopy

ddPCR

HPLC

SDS-PAGE

Capillary Electrophoresis

Western blot

Dot blot

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

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. 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, 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 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

This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Senior Specialist Quality Assurance - Biochemistry leads quality assurance initiatives by ensuring regulatory compliance, managing risk, driving quality system effectiveness, supporting product lifecycle quality activities, and providing technical leadership across cross-functional teams.

What You’ll Work On

• Maintain and enhance Quality System effectiveness, ensuring compliance with site, divisional, corporate, and regulatory requirements.
• Lead and manage quality-focused projects, defining objectives, milestones, timelines, and delivering successful outcomes.
• Provide innovative and compliant solutions to complex quality and operational challenges while aligning with organizational goals.
• Ensure Quality System compliance by identifying, addressing, and escalating nonconformance issues as appropriate.
• Conduct risk assessments and develop risk management documentation to identify, evaluate, mitigate, and control product and process risks.
• Investigate and resolve complex product testing issues, ensuring thorough analysis, documentation, and effective corrective actions.
• Support Design Control and Change Management processes, including change justification, impact assessments, and identification of critical parameters.
• Serve as a Quality Engineering leader, driving quality initiatives from product development through launch while collaborating with cross-functional teams and suppliers.
• Act as a Subject Matter Expert (SME) for validation activities, providing technical guidance and ensuring validation compliance.
• Mentor and train quality professionals and technicians, influencing project direction, supporting decision-making, and promoting quality excellence across the organization.

Required Qualifications

• Bachelors degree in Life Science, Engineering, or closely related discipline. Or an equivalent combination of education and work experience.
• Minimum 5 years in quality or related field experience; Less experience may be appropriate with advanced degree.

Preferred Qualifications

• Masters degree is preferred.
• Supervisory experience is a plus.
• Solid understanding of diagnostic product manufacturing and testing, including diagnostic methods and applications.
• Proven expertise in troubleshooting, product and process improvement, QC release testing, change control, compliance, and audit readiness (internal and external).
• Demonstrated ability to lead cross-functional projects, test method optimization, and test method reliability improvements
• Demonstrated knowledge and testing experience of bioanalytical methods (mass spectrometry, UV-Vis and infrared spectroscopy, ddPCR, HPLC, SDS-PAGE, Capillary Electrophoresis, western/dot blot).
• Familiarity with performance metrics and their application in driving continuous improvement.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $86,700.00 - $173,300.00. In specific locations, the pay range may vary from the range posted.