Senior QA Biochemistry Specialist - Diagnostics Impact

Thornton Tomasetti; Illinois; On-site; USD 87,000 - 173,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Quality Assurance

Cross-functional leadership

Validation

Change Control

Bioanalytical methods

Education

Bachelor's degree in Life Science or Engineering

Master's degree (preferred)

Tools

Mass spectrometry

HPLC

SDS-PAGE

Capillary Electrophoresis

Job description

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