Senior Specialist Quality Assurance- Biochemistry

Thornton Tomasetti; Illinois; Sur place; USD 87 000 - 173 000; Plein temps

Résumé du poste

Abbott Park, IL (Lake Bluff area) seeks a Senior Specialist Quality Assurance - Biochemistry to strengthen the Quality System and guide cross-functional projects ensuring regulatory compliance across the site. The role leads investigations, validation activities, and change management to enable safe, effective diagnostics manufacturing.

You will mentor QA professionals, collaborate with suppliers and internal teams, and drive risk assessments and continuous improvement in the Biochemistry

Qualifications

• Bachelor’s degree or higher in Life Science, Engineering, or related field; 5+ years in quality or related field.
• Master’s degree preferred; supervisory experience a plus.
• Solid understanding of diagnostic product manufacturing, testing, and QC release testing.

Responsabilités

• Maintain and enhance Quality System effectiveness, ensuring compliance with site, divisional, corporate, and regulatory requirements.
• Lead and manage quality-focused projects with clear objectives, milestones, and timelines.
• Provide innovative solutions to quality and operational challenges while aligning with organizational goals.
• Identify, address, and escalate nonconformance issues to ensure compliance.
• Perform risk assessments and develop risk management documentation for product and process risks.
• Investigate and resolve complex product testing issues with thorough documentation and corrective actions.
• Support Design Control and Change Management processes, including impact assessments.
• Act as a Quality Engineering SME, driving initiatives from development through launch and mentoring staff.

Connaissances

Quality Assurance

Cross-functional leadership

Validation

Change Control

Bioanalytical methods

Formation

Bachelor's degree in Life Science or Engineering

Master's degree (preferred)

Outils

Mass spectrometry

HPLC

SDS-PAGE

Capillary Electrophoresis

Description du poste

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.

Senior Specialist Quality Assurance - Biochemistry

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.

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 Details

• JOB FAMILY: Operations Quality
• DIVISION: TM Transfusion Medicine
• LOCATION: United States > Abbott Park : AP08B
• 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), 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

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.