Batch Record
A Batch Record is a detailed document that tracks how a product is made in chemical or pharmaceutical manufacturing. Think of it like a cooking recipe combined with a diary - it records every step, ingredient, and check made while making a product. This documentation is especially important in regulated industries where companies need to prove they're making products safely and consistently. Manufacturing professionals use these records to show quality control, meet legal requirements, and track production history. You might also hear it called a "Batch Manufacturing Record," "Production Record," or "Manufacturing Batch Record."
Examples in Resumes
Managed and reviewed Batch Record documentation for 50+ product runs per month
Trained production staff on proper Batch Manufacturing Record completion procedures
Led the digitization of paper-based Manufacturing Batch Record systems to electronic format
Ensured compliance by maintaining accurate Batch Record documentation for FDA requirements
Typical job title: "Batch Record Reviewers"
Also try searching for:
Where to Find Batch Record Reviewers
Professional Organizations
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where you discover a deviation in a completed batch record?
Expected Answer: A strong answer should include investigating the root cause, assessing impact on product quality, implementing corrective actions, and ensuring proper documentation of the deviation handling process.
Q: What experience do you have in improving batch record processes?
Expected Answer: Look for candidates who can discuss implementing electronic systems, streamlining review procedures, or creating better training programs for staff completing records.
Mid Level Questions
Q: What are the key components you look for when reviewing a batch record?
Expected Answer: Should mention checking for completeness, accuracy, proper signatures, correct calculations, any deviations, and ensuring all critical steps were properly documented.
Q: How do you ensure batch records comply with regulatory requirements?
Expected Answer: Should discuss knowledge of FDA/regulatory guidelines, understanding of GMP requirements, verification of proper documentation, and importance of thorough review.
Junior Level Questions
Q: What is the purpose of a batch record?
Expected Answer: Should explain that it documents the production process, ensures product quality, maintains regulatory compliance, and provides traceability for manufacturing.
Q: What information should be included in a batch record?
Expected Answer: Should mention basic elements like raw materials used, equipment used, operator information, dates, times, measurements, and quality checks.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of batch record requirements
- Attention to detail in documentation
- Knowledge of Good Manufacturing Practices (GMP)
- Basic quality control procedures
Mid (2-5 years)
- Batch record review and approval
- Deviation management
- Training others on documentation practices
- Understanding of regulatory requirements
Senior (5+ years)
- Process improvement implementation
- Electronic batch record system management
- Regulatory audit experience
- Team leadership and training program development
Red Flags to Watch For
- No understanding of Good Manufacturing Practices (GMP)
- Careless attitude towards documentation accuracy
- Lack of attention to detail
- No knowledge of regulatory requirements in manufacturing
- Unable to explain the importance of proper documentation
