Senior Specialist Quality Assurance- Biochemistry

Abbott; Chicago (IL); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan with

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL is seeking a Senior Specialist Quality Assurance for Biochemistry to drive QA initiatives, ensure regulatory compliance, and lead quality activities across the product lifecycle. You’ll mentor QA professionals, manage risk, support Design Control and Change Management, and collaborate with cross-functional teams and suppliers to deliver high-quality diagnostics products.

The role requires a Bachelor’s in Life Science or Engineering and 5 years of QA experience, including

Qualifications

• Bachelor’s degree in Life Science or Engineering or related field.
• Minimum 5 years in quality or related field experience; higher for advanced degree.

Responsibilities

• Maintain and enhance Quality System effectiveness and ensure regulatory compliance.
• Lead quality-focused projects with defined goals, milestones, and timelines.
• Provide compliant solutions to complex quality and operational challenges.
• Identify and escalate nonconformance issues and conduct risk assessments.
• Investigate product testing issues and implement effective corrective actions.
• Support Design Control and Change Management processes and assess impact.
• Act as a Quality Engineering leader across product development to launch.
• Serve as SME for validation activities and provide technical guidance.
• Mentor and train quality professionals to promote quality excellence.

Skills

Quality assurance

Regulatory compliance

Risk management

Cross-functional collaboration

Project leadership

Education

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

Tools

Mass spectrometry

HPLC

SDS-PAGE

Capillary Electrophoresis

Western blot

UV-Vis spectroscopy

Infrared spectroscopy

ddPCR

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.

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. 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 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.

JOB FAMILY:

Operations Quality

DIVISION:

TM Transfusion Medicine

LOCATION:

United States > Abbott Park : AP08B

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), Routine work with chemicals, Work requiring repeated bending, stooping, squatting or kneeling

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