Quality Systems Specialist — GMP & Compliance

AbbVie Inc.; North Chicago (IL); On-site; USD 66,000 - 126,000; Full time

Benefits offered by this job

Paid time off

401(k) plan

Job summary

AbbVie seeks a Quality Systems Associate Specialist to provide QA support across manufacturing processes including documentation, device QA, labeling, validation, training and CAPA. The role ensures compliance with corporate and governmental regulations from raw materials inspection to final shipment.

Key activities include regulating quality documentation, supporting audits, and implementing improvements within a cross-functional team. Strong communication and technical knowledge are essential.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards for device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently with direction as needed.
• Strong oral and written communication skills.

Responsibilities

• Assist with integration and support of quality regulations for 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 following approved templates.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance and efficiency.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate improvements.

Skills

Quality assurance

Regulatory knowledge

Process sciences

Manufacturing operations

Education

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Job description

AbbVie seeks a Quality Systems Associate Specialist to provide QA support across manufacturing processes including documentation, device QA, labeling, validation, training and CAPA. The role ensures compliance with corporate and governmental regulations from raw materials inspection to final shipment.

Key activities include regulating quality documentation, supporting audits, and implementing improvements within a cross-functional team. Strong communication and technical knowledge are essential.