Biochemistry QA Lead – Quality Systems & Validation

Regulatory Jobs; Illinois; On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Health coverage (HIP PPO)

Retirement savings plan with employer

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL is seeking a Senior Specialist Quality Assurance - Biochemistry to lead quality assurance initiatives, drive risk management, and ensure compliance across product life cycles in the Transfusion Medicine diagnostics division.

You will mentor quality staff, oversee validation, change control, and design control activities, and collaborate with cross-functional teams to deliver high-quality outcomes.

Qualifications

• Bachelor's 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.

Responsibilities

• 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.

Job description

Abbott Park, IL is seeking a Senior Specialist Quality Assurance - Biochemistry to lead quality assurance initiatives, drive risk management, and ensure compliance across product life cycles in the Transfusion Medicine diagnostics division.

You will mentor quality staff, oversee validation, change control, and design control activities, and collaborate with cross-functional teams to deliver high-quality outcomes.