Senior QA Biochemistry | Quality Systems Leader

Abbott; Chicago (IL); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan with

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL is seeking a Senior Specialist Quality Assurance for Biochemistry to drive QA initiatives, ensure regulatory compliance, and lead quality activities across the product lifecycle. You’ll mentor QA professionals, manage risk, support Design Control and Change Management, and collaborate with cross-functional teams and suppliers to deliver high-quality diagnostics products.

The role requires a Bachelor’s in Life Science or Engineering and 5 years of QA experience, including

Qualifications

• Bachelor’s degree in Life Science or Engineering or related field.
• Minimum 5 years in quality or related field experience; higher for advanced degree.

Responsibilities

• Maintain and enhance Quality System effectiveness and ensure regulatory compliance.
• Lead quality-focused projects with defined goals, milestones, and timelines.
• Provide compliant solutions to complex quality and operational challenges.
• Identify and escalate nonconformance issues and conduct risk assessments.
• Investigate product testing issues and implement effective corrective actions.
• Support Design Control and Change Management processes and assess impact.
• Act as a Quality Engineering leader across product development to launch.
• Serve as SME for validation activities and provide technical guidance.
• Mentor and train quality professionals to promote quality excellence.

Skills

Quality assurance

Regulatory compliance

Risk management

Cross-functional collaboration

Project leadership

Education

Bachelor's degree in Life Science, Engineering, or closely related discipline

Tools

Mass spectrometry

HPLC

SDS-PAGE

Capillary Electrophoresis

Western blot

UV-Vis spectroscopy

Infrared spectroscopy

ddPCR

Job description

Abbott Park, IL is seeking a Senior Specialist Quality Assurance for Biochemistry to drive QA initiatives, ensure regulatory compliance, and lead quality activities across the product lifecycle. You’ll mentor QA professionals, manage risk, support Design Control and Change Management, and collaborate with cross-functional teams and suppliers to deliver high-quality diagnostics products.

The role requires a Bachelor’s in Life Science or Engineering and 5 years of QA experience, including