Documentation Coordinator II

AbbVie Batch Record Reviewer

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

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 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 AbbVie departments, external customers, and regulatory agencies
• May release batch records in electronic systems according to global, local, customer, and regulatory requirements

Qualifications

• Minimum High School graduate; Bachelor's or Associate's degree desired
• 2+ years of overall experience in Manufacturing, Quality or Engineering
• Minimum 5 years of experience in a manufacturing/finishing environment is desired
• 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

Additional Information

• 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.

AbbVie 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, click here to learn more:

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Pay Range: $23.1 - 41.6 USD

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.