Batch Record Specialist
Celcuity
June 30, 2026
Remote friendly (United States)
United States
Operations
Position Summary
Seeking a Batch Record Specialist who reports to the Executive Director, Quality Assurance. Responsible for preparing technical and final product release and ensuring manufacturing records are compiled, reviewed, and completed in a compliant and efficient manner in accordance with SOPs and applicable regulatory/GMP requirements.
Responsibilities
- Review and verify executed batch records of APIs, drug products, labeling, and packaging
- Review and verify analytical data
- Assess quality control results against acceptable limits
- Review and complete records to ensure compliance with SOPs and regulatory requirements
- Communicate with CMOs on missing documentation and error corrections
- Archive full batch documentation in eQMS (e.g., Veeva)
- Report variances, errors, and deviations to supervisor
- Manage records in eQMS
- Collaborate on complaint and/or nonconformance reports
- Write and implement QA standard operating procedures and work instructions
- Support inspection readiness (as needed)
- Other duties as assigned
Qualifications
- Bachelor’s degree in health/life sciences (or related) or relevant experience
- 3+ years in quality assurance, commercial pharmaceutical drug manufacturing, and GMPs (pharma/biotech)
- Analytical education/background (preferred)
- Working knowledge of FDA/EU requirements and GxP/ICH standards
- Experience supporting regulatory inspections and interacting with health authorities
Skills
- Strong written/verbal communication; able to influence at all levels
- Attention to detail; manage multiple processes/documentation
- Advanced MS Office (Word, Excel, PowerPoint)
- Strong organizational skills; independent and team-oriented
- Critical thinking, sound decision-making, continuous improvement mindset
Benefits
- Annual performance incentive bonus; new hire equity package
- Medical, dental, vision insurance; 401(k) match; PTO; paid holidays
Application
- Submit via the page/website through which the role is posted (no recruiter/staffing agency direct contact).
Seeking a Batch Record Specialist who reports to the Executive Director, Quality Assurance. Responsible for preparing technical and final product release and ensuring manufacturing records are compiled, reviewed, and completed in a compliant and efficient manner in accordance with SOPs and applicable regulatory/GMP requirements.
Responsibilities
- Review and verify executed batch records of APIs, drug products, labeling, and packaging
- Review and verify analytical data
- Assess quality control results against acceptable limits
- Review and complete records to ensure compliance with SOPs and regulatory requirements
- Communicate with CMOs on missing documentation and error corrections
- Archive full batch documentation in eQMS (e.g., Veeva)
- Report variances, errors, and deviations to supervisor
- Manage records in eQMS
- Collaborate on complaint and/or nonconformance reports
- Write and implement QA standard operating procedures and work instructions
- Support inspection readiness (as needed)
- Other duties as assigned
Qualifications
- Bachelor’s degree in health/life sciences (or related) or relevant experience
- 3+ years in quality assurance, commercial pharmaceutical drug manufacturing, and GMPs (pharma/biotech)
- Analytical education/background (preferred)
- Working knowledge of FDA/EU requirements and GxP/ICH standards
- Experience supporting regulatory inspections and interacting with health authorities
Skills
- Strong written/verbal communication; able to influence at all levels
- Attention to detail; manage multiple processes/documentation
- Advanced MS Office (Word, Excel, PowerPoint)
- Strong organizational skills; independent and team-oriented
- Critical thinking, sound decision-making, continuous improvement mindset
Benefits
- Annual performance incentive bonus; new hire equity package
- Medical, dental, vision insurance; 401(k) match; PTO; paid holidays
Application
- Submit via the page/website through which the role is posted (no recruiter/staffing agency direct contact).