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Product Review Coordinator II
Job in
Newark, Essex County, New Jersey, 07175, USA
Listed on 2026-06-18
Listing for:
PowerToFly
Full Time
position Listed on 2026-06-18
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Manufacturing / Production
Quality Engineering
Job Description & How to Apply Below
Job Description
The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to Abb Vie policies and procedures and performs transactions in inventory systems to release the batch for further processing.
ResponsibilitiesReview and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batch.
- Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved.
- Ensure all in-process and release testing is complete and all quality holds are released.
- Interface with various electronic databases/systems to interpret data pertinent for release to specific countries.
- Ensure batch records are retained and filed securely.
- Ensure quality goals are met and all practices and procedures comply with Company policies and applicable regulations.
- Interact with other Abb Vie departments, external customers, and regulatory agencies.
- May release batch records in electronic systems according to global, local, customer, and regulatory requirements.
- Minimum high school graduate.
- 2+ years of overall experience in Manufacturing, Quality or Engineering.
- Knowledge of GMP regulations and standards affecting pharmaceutical products.
- Good analytical skills and attention to detail.
- Good interpersonal relations / communications skills.
- Good verbal and written communication skills.
- Must be available to work daily overtime, including weekends, as needed.
- Bachelor's or Associate's degree highly desired.
- Experience in quality batch records or electronic batch records highly desirable.
- Minimum 5 years of experience in a manufacturing/finishing environment is desired.
Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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