Product Review Coordinator II

The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to AbbVie policies and procedures and performs transactions in inventory systems to release the batch for further processing.

Responsibilities
- Review and audit data and records generated by Manufacturing and Packaging Operations for a material/product batch
- Ensure batch record errors are corrected, all components are present, and exception documents are referenced and approved
- Ensure in-process and release testing is complete and all Quality holds are released
- Interface with electronic databases/systems to interpret data for release to specific countries
- Ensure batch records are retained and filed securely
- Ensure Quality goals are met and practices/procedures comply with policies and applicable regulations
- Interact with other AbbVie departments, external customers, and regulatory agencies
- May release batch records in electronic systems per global/local/customer/regulatory requirements

Qualifications
- Minimum High School graduate
- 2+ years in Manufacturing, Quality, or Engineering
- Knowledge of GMP regulations/standards for pharmaceutical products
- Good analytical skills and attention to detail
- Good interpersonal/communications skills; good verbal and written communication
- Available for daily overtime including weekends as needed

Preferred
- Bachelor’s or Associate’s degree highly desired
- Experience in quality batch records or electronic batch records highly desirable
- Minimum 5 years manufacturing/finishing environment desired

Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
- Eligible for short-term incentive programs