Quality Control Inspector II

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
- Correct batch record errors, ensure all components are present, and that 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 release data for specific countries
- Ensure batch records are retained and filed securely
- Ensure Quality goals are met and practices/procedures comply with company 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, and regulatory requirements

Qualifications:
- Minimum High School graduate; Bachelor’s or Associate’s degree desired
- 2+ years’ experience in Manufacturing, Quality, or Engineering
- Minimum 5 years’ experience in a manufacturing/finishing environment (desired)
- Knowledge of GMP regulations and standards for pharmaceutical products
- Good analytical skills and attention to detail
- Good interpersonal/communication skills (verbal and written)
- Must be available for daily overtime including weekends as needed

Benefits (as stated): paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) to eligible employees; eligible for short-term incentive programs