Senior QA Lead – Product Development & Compliance

AbbVie Inc.; Chicago (IL); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

401(k)

Résumé du poste

AbbVie Inc. in Chicago, IL, seeks a Quality Assurance professional to support clinical supplies and batch disposition activities, ensuring regulatory compliance and timely delivery to patients.

You will partner with cross-functional teams, review batch records, participate in audits, and drive continuous improvements in QA processes. Strong communication and problem-solving skills are required along with 4+ years in QA/pharma.

Qualifications

• Bachelor's degree in life sciences or related field.
• 4+ years of industry experience in Quality Assurance, production, or testing in pharma.
• Broad understanding of pharmaceutical manufacturing & GMP requirements (US/EU) preferred.
• Experience coordinating and planning complex activities.

Responsabilités

• Review and approve batch records and release batches or analytical records.
• Lead/assist in audits by regulatory agencies and customers.
• Provide quality approvals in the materials management system and manage exceptions/CA/PA actions.
• Review/approve clinical documentation and specifications as applicable.
• Lead project teams to support product development and resolve quality issues.
• Generate and report quality metrics to management and prioritize QA timelines.

Connaissances

Quality Assurance

Regulatory knowledge

Project coordination

Communication

Formation

Bachelor's degree in life sciences or related field

Description du poste

AbbVie Inc. in Chicago, IL, seeks a Quality Assurance professional to support clinical supplies and batch disposition activities, ensuring regulatory compliance and timely delivery to patients.

You will partner with cross-functional teams, review batch records, participate in audits, and drive continuous improvements in QA processes. Strong communication and problem-solving skills are required along with 4+ years in QA/pharma.