Product Review Coordinator II

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.

Review 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

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more: