Purpose:

This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch 
disposition activities and ensuring high-quality clinical supplies that are compliant with global 
regulatory requirements and standards are delivered to patients. This is achieved by effectively 
partnering with the business, ensuring risks are mitigated appropriately and supporting efficient 
review of clinical supply batches to support continued uninterrupted access to clinical supplies. 
The successful candidate will be able to manage multiple tasks and adjust priorities based on 
supply needs. This position requires the ability to positively interact with multiple functional 
areas quickly and effectively resolve batch record documentation related issues, ensuring 
schedules are maintained and material is readily available.

Responsibilities: 

• Review and approve batch records and release batches or analytical records. 
• Write/review/approve exception documents and product complaints (as applicable)  corrective actions/preventive actions (CA/PA) and ensure they meet timeliness  requirements.
• Assist in the preparation of audits conducted by regulatory agencies, customers, and GxP Compliance.
• Provide quality approvals in materials management system as defined by procedures.
• Write and/or review policies/processes/procedures and related documents.
• Actively participate on assigned project team(s) to support the product development  process and timelines by using expertise to anticipate/resolve quality issues. 
• Generate and report quality metrics to management.
• Participate with support groups in developing/prioritizing QA activity timelines.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
• Provide quality oversight on the manufacturing floor, as needed

Significant Work Activities:

- Work in a clean room environment