Batch Record Specialist

Role Summary

Batch Record Specialist — Remote. Reports to the Executive Director, Quality Assurance. Supports quality assurance objectives and helps establish systems and processes that meet quality standards and regulatory requirements. Responsible for preparing the technical and final release of products and ensuring manufacturing records are compiled, reviewed, and completed in a compliant and efficient manner in accordance with SOPs and GMP requirements.

Responsibilities

• Review and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging
• Review and verify analytical data
• Review and assess relevant quality control results against acceptable limits
• Review and complete records ensuring compliance with SOPs and regulatory regulations
• Communicate with CMOs on missing documentation and error corrections
• Archive entire batch documentation in an electronic quality management system (eQMS)
• Report all variances, errors, and deviations to supervisor
• Manage records in eQMS
• Collaborate on complaint and/or nonconformance reports
• Write and implement standard operating procedures and work instructions for QA processes
• Support inspection readiness, as needed
• Other duties as assigned

Qualifications

• Bachelor’s degree in health or life sciences, or related field; or relevant experience
• Minimum of 3 years of experience in quality assurance, commercial pharmaceutical drug manufacturing, and GMPs in the pharmaceutical/biotech industry
• Analytical education/background preferred
• Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, ICH)
• Experience in supporting regulatory inspections and interacting with regulatory agencies
• Adept at collaborating and communicating effectively across diverse roles and levels
• Excellent written and verbal communication skills with ability to influence and build credibility
• Attention to detail and ability to manage multiple processes and documentation
• Strong technical and analytical skills with advanced knowledge in MS Office (Word, Excel, PowerPoint)
• Ability to work in a team and independently to ensure timely, accurate completion of assignments
• Outstanding organizational skills and ability to prioritize
• Independent and sound decision-making skills; ability to think critically in a fast-paced environment
• Continuous improvement mindset; drive for innovation and efficiencies
• Flexible and willing to learn; adapt to business and site needs
• Positive, approachable, and professional attitude