Welcome to AbbVie, a global biopharmaceutical company dedicated to discovering and delivering innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We are currently seeking a meticulous and detail-oriented Batch Record Reviewer to join our team.In this role, you will play a critical part in ensuring the quality and compliance of our products by reviewing and approving batch records in accordance with regulatory standards. You will have the opportunity to work with a team of passionate individuals who are committed to making a difference in patients' lives.To excel in this position, we are looking for someone with a strong background in Quality Assurance, excellent attention to detail, and an understanding of cGMP regulations. If you are driven, self-motivated, and have a passion for upholding high-quality standards, we encourage you to apply for this exciting opportunity.
- Review and approve batch records for compliance with regulatory standards and company policies.
- Ensure accuracy and completeness of batch records, including documentation of all manufacturing and testing activities.
- Collaborate with cross-functional teams to resolve any discrepancies or issues identified during batch record review.
- Maintain a thorough understanding of cGMP regulations and company procedures to ensure compliance.
- Communicate any changes or updates to batch records to relevant stakeholders.
- Participate in investigations related to batch record discrepancies or non-conformances.
- Identify areas for improvement in batch record processes and suggest solutions to enhance efficiency and compliance.
- Keep accurate and organized records of batch record review activities and findings.
- Provide support during regulatory inspections and audits by presenting batch record documentation and responding to inquiries.
- Train and mentor other team members on batch record review processes and procedures.
- Stay updated on industry trends and advancements in batch record review and quality assurance practices.
- Collaborate with the Quality Assurance team to develop and implement quality improvement initiatives.
- Adhere to all company safety and compliance protocols and report any potential risks or hazards.
- Uphold AbbVie's mission and values by promoting a culture of integrity, teamwork, and excellence.
Bachelor's Degree In A Relevant Scientific Field, Such As Chemistry, Biology, Or Pharmaceutical Sciences.
Minimum Of 3-5 Years Of Experience In Batch Record Review And Documentation In A Pharmaceutical Or Biotechnology Company.
In-Depth Knowledge Of Current Good Manufacturing Practices (Cgmp) Regulations And Guidelines.
Strong Attention To Detail And Ability To Identify Errors Or Discrepancies In Batch Records.
Excellent Communication And Organizational Skills, With The Ability To Work Collaboratively With Cross-Functional Teams And Provide Clear And Concise Feedback.
Quality Assurance
Process Improvement
Communication Skills
Data Analysis
Time Management
Attention to detail
Problem Solving
Technical Writing
Batch record review
Documentation management
GMP compliance
Communication
Conflict Resolution
Customer Service
Leadership
creativity
Teamwork
Adaptability
Problem-Solving
Time-Management
Decision-making
According to JobzMall, the average salary range for a Batch Record Reviewer in Chicago, IL, USA is between $40,000 and $60,000 per year. However, this can vary depending on factors such as experience, education, and the specific company and industry.
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AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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