Senior Product Development QA Lead

BioSpace; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

401(k) plan

Job summary

AbbVie seeks a QA professional to support batch disposition activities and ensure high-quality clinical supplies compliant with global regulatory requirements. The role emphasizes risk mitigation, project coordination, and timely issue resolution to keep material flow uninterrupted.

The candidate should have 6+ years in QA or related fields, strong GMP knowledge, and a capability to collaborate across functions, lead process improvements, and manage audits with regulatory bodies.

Qualifications

• Bachelor's in life sciences or engineering or equivalent experience.
• Master's degree preferred but not required based on experience.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Write, review, and approve processes and procedures.
• Lead or assist audits conducted by regulatory agencies, customers, and GxP compliance.
• Review regulations for impact on R&D and implement changes.
• Provide routine area management support and act as backup to manager.
• Support daily product release activities as applicable.

Skills

Quality Assurance

GMP knowledge

Problem solving

Project management

Auditing

Education

Bachelor's degree in life sciences or engineering

Master's degree preferred

Job description

AbbVie seeks a QA professional to support batch disposition activities and ensure high-quality clinical supplies compliant with global regulatory requirements. The role emphasizes risk mitigation, project coordination, and timely issue resolution to keep material flow uninterrupted.

The candidate should have 6+ years in QA or related fields, strong GMP knowledge, and a capability to collaborate across functions, lead process improvements, and manage audits with regulatory bodies.