Batch Record Reviewer II (3rd Shift)

AbbVie • Waco, TX

15h

About The Position

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube, LinkedIn and Tik Tok . The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records, performs transactions in inventory systems to release batches for further processing (Packaging) and coordinates problem-solving activities, including solution implementation.

Requirements

• Minimum High School graduate; Bachelor's or Associate's degree desired
• 2+ years of overall experience in Manufacturing, Quality or Engineering
• Minimum 5 years experience in a Manufacturing and/or Finishing and/or Packaging environment is desired
• Minimum 2 years experience in Batch Record Release strongly preferred
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Good verbal and written communication skills
• Demonstrated analytical skills and attention to detail
• Good interpersonal relations/communications skills
• Must be available to work daily overtime, including weekends, as needed
• This is a 3rd Shift position: Hours: 7pm-7:30am, Sunday - Tuesday every other Saturday

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 Quality goals are met, and all practices and procedures comply with Company policies and applicable regulations
• Develop and implement process improvements for improved compliance and/or efficiencies
• Complete basic calculations for product yield.
• Communicate batch release progress or delays to quality and materials management
• Ensure all in-process and release testing is complete and all Quality holds are released
• Release batch records in electronic systems according to global, local, customer, and regulatory requirements
• Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
• Interact with other AbbVie departments, external customers, and regulatory agencies
• Ensure batch records are retained and filed securely
• Lead problem-solving activities and coordinate the implementation of identified solutions

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED