Senior Specialist Quality Assurance- Biochemistry

Thornton Tomasetti; Northern (KY); On-site; USD 87,000 - 173,000; Full time

Job summary

Abbott Park, IL is seeking a Senior Specialist Quality Assurance - Biochemistry to lead QA initiatives across cross-functional teams in Transfusion Medicine diagnostics.

Role focuses on regulatory compliance, risk assessment, change control, and validation activities throughout product lifecycle, with design-control support and mentoring of staff.

Qualifications

• Bachelors in Life Science, Engineering, or closely related field.
• Minimum 5 years in quality or related field; advanced degree may adjust the requirement.
• Masters degree preferred.
• Solid understanding of diagnostic product manufacturing and testing.
• Experience with change control, audit readiness, and QC release testing.
• Ability to lead cross-functional projects and test method improvements.
• Practical knowledge of listed bioanalytical methods.

Responsibilities

• Maintain and enhance Quality System effectiveness according to regulatory requirements.
• Lead quality-focused projects with clear objectives, milestones, and timelines.
• Provide innovative, compliant solutions for quality and operational challenges.
• Ensure Quality System compliance by addressing nonconformances and risks.
• Investigate and resolve complex product testing issues with proper action plans.
• Support Design Control and Change Management processes with impact assessments.
• Serve as SME for validation activities and ensure validation compliance.
• Mentor quality professionals and influence project direction.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Cross-functional Leadership

Education

Bachelor's degree in Life Science or related

Master's degree preferred

Tools

Mass Spectrometry

HPLC

Capillary Electrophoresis

SDS-PAGE

Western Blot

ddPCR

UV-Vis Spectroscopy

IR Spectroscopy

Job description

Senior Specialist Quality Assurance- Biochemistry page is loaded## Senior Specialist Quality Assurance- Biochemistrylocations: United States - Illinois - Abbott Parktime type: Tempo Integralposted on: Publicado hojejob requisition id: 31163633Abbott 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.Descritivo de Cargo**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 student debt program, and 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:**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 LinkedIn at, and on Facebook at .**The base pay for this position is**$86,700.00 - $173,300.00In specific locations, the pay range may vary from the range posted.Família de CargoOperations QualityDivisãoTM Transfusion MedicineLocalidadeUnited States > Abbott Park: AP08BLocalidades AdicionaisTurno de TrabalhoStandardViagemYes, 5 % of the TimeVigilância médicaNot ApplicableAtividades de trabalho significativasContinuous 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 kneelingAbbott 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf