Quality Systems Specialist — Compliance & CAPA Lead

AbbVie Inc.; Chicago (IL); On-site; USD 75,000 - 110,000; Full time

Job summary

AbbVie Inc. is seeking a Quality Systems Associate Specialist to support quality assurance across manufacturing processes, including drugs, biologics and devices.

The role ensures compliance with corporate and governmental regulations from raw material inspection through shipment. Responsibilities include coordinating quality documentation, supporting audits, creating system documentation, and driving improvements within the quality framework.

Qualifications

• Bachelor's degree in a technical/scientific field is preferred.
• 3+ years’ experience in quality assurance or relevant experience.
• Strong knowledge of QA systems and GMP compliance.

Responsibilities

• Assist with integration and support of quality regulations across drug, biologics, device, and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Design effective quality systems, procedures and processes within cross-functional teams.
• Perform assessments to determine compliance and identify gaps for improvements.
• Participate in training and education programs for quality assurance.

Skills

Quality assurance

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Job description

AbbVie Inc. is seeking a Quality Systems Associate Specialist to support quality assurance across manufacturing processes, including drugs, biologics and devices.

The role ensures compliance with corporate and governmental regulations from raw material inspection through shipment. Responsibilities include coordinating quality documentation, supporting audits, creating system documentation, and driving improvements within the quality framework.