Senior QA Biochemistry: Validation & Design Control Lead

Abbott Laboratories; Illinois; On-site; USD 87,000 - 173,000; Full time

Job summary

Abbott Laboratories, based in Abbott Park, IL, seeks a Senior Specialist Quality Assurance - Biochemistry to lead QA initiatives, ensure regulatory compliance, and drive risk management across cross-functional teams.

The role involves supporting Design Control, Change Management, and validation activities while mentoring quality professionals to uphold QC standards and product quality throughout the lifecycle.

Qualifications

• Bachelor's degree in Life Science, Engineering, or closely related discipline or equivalent experience.
• Minimum 5 years in quality or related field experience; advanced degree may reduce experience need.
• Master's degree preferred; supervisory experience is a plus; knowledge of diagnostic product manufacturing advantageous.

Responsibilities

• Maintain and enhance Quality System effectiveness, ensuring regulatory compliance.
• Lead and manage quality-focused projects with clear objectives, milestones, and timelines.
• Provide compliant solutions to complex quality and operational challenges aligned with goals.
• Identify, address, and escalate nonconformance issues to ensure QA compliance.
• Conduct risk assessments and develop risk management documentation for product/process risks.
• Investigate and resolve complex product testing issues with thorough analysis and corrective actions.
• Support Design Control and Change Management processes with impact assessments.
• Serve as a Quality Engineering leader driving initiatives from development through launch.
• Act as SME for validation activities and provide guidance on validation compliance.
• Mentor and train quality professionals, influencing project direction and promoting excellence across the organization.

Skills

Quality Assurance

Regulatory compliance

Risk assessment

Quality systems

Cross-functional collaboration

Validation activities

Test method optimization

Audit readiness

Education

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

Equivalent combination of education and work experience

Master's degree (preferred)

Tools

Mass spectrometry

UV-Vis spectroscopy

Infrared spectroscopy

ddPCR

HPLC

SDS-PAGE

Capillary Electrophoresis

Western blot

Dot blot

Job description

Abbott Laboratories, based in Abbott Park, IL, seeks a Senior Specialist Quality Assurance - Biochemistry to lead QA initiatives, ensure regulatory compliance, and drive risk management across cross-functional teams.

The role involves supporting Design Control, Change Management, and validation activities while mentoring quality professionals to uphold QC standards and product quality throughout the lifecycle.