Documentation Coordinator II
AbbVie
2 months ago
On-site
Branchburg, NJ
$23.10 - $41.60 USD yearly
Operations
Job Description:
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 or 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 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 affecting pharmaceutical products
- Good analytical skills and attention to detail
- Good interpersonal/communications skills (verbal and written)
- Must be available for daily overtime, including weekends, as needed
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 or 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 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 affecting pharmaceutical products
- Good analytical skills and attention to detail
- Good interpersonal/communications skills (verbal and written)
- Must be available for daily overtime, including weekends, as needed