Quality Compliance Specialist II
Core
Support site quality compliance programs to ensure adherence to AbbVie Policies and current Good Manufacturing Practices (cGMP) requirements per regulatory standards.
Role type
Quality Compliance Specialist
Builds
Inspection readiness for regulatory audits, quality management systems, and regulatory submissions
Domain
Pharmaceutical/Biopharmaceutical Manufacturing
Required skills
cGMP compliance, internal/external audit support, regulatory submission management, quality risk management, data governance, product complaint handling, recall management
Preferred skills
Audit management, product review, customer complaints, management review, quality metrics, quality risk management, data governance, small molecule API or Biologics manufacturing experience, knowledge of ICH/CFR/Eudralex/PIC/S
Technologies
GMP certification systems, Quality Management Systems (QMS)
Responsibilities
Support internal and external inspection management activities, assist in regulatory filing submissions and maintenance of HSA Manufacturing Licenses, support data integrity training and audit trail reviews, execute mock recall exercises, track quality risk management activities
Seniority
Mid-level, hands-on IC
