Product Review Coordinator II

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
• 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
• Preferred
• 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:
• 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

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.

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