Senior Specialist Quality Assurance- Biochemistry
Abbott
Summary
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.
Job description
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.
Requirements
- Bachelors degree in Life Science, Engineering, or closely related discipline
- Minimum 5 years in quality or related field experience
- Masters degree is preferred
- Supervisory experience is a plus
- Solid understanding of diagnostic product manufacturing and testing
- Proven expertise in troubleshooting, product and process improvement, QC release testing, change control, compliance, and audit readiness
- 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
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.