Job Title:
Batch Record Review - 1904031

Company: ProQualityNetwork

Location: Harmans, MD

Created: 2024-04-20

Job Type: Full Time

Job Description:

Job Title: Batch Record Reviewer Facility: Cell & Gene Manufacturing Work Type: 100% Onsite Location: Maryland, USA Job Description: We are seeking a highly skilled and detail-oriented Batch Record Reviewer to join our Cell & Gene Manufacturing facility in Maryland, USA. In this role, you will be responsible for meticulously reviewing batch records to ensure accuracy, compliance, and adherence to regulatory standards. 🧪🔍 Key Responsibilities: Review batch records for completeness and accuracy, verifying all data and documentation. ✅ Ensure batch records comply with SOPs, GMP guidelines, and regulatory requirements. 📋 Identify and address any discrepancies, deviations, or non-conformities in batch records. 🚫🔍 Collaborate with production teams to resolve issues and ensure timely completion of batch record reviews. 🤝 Maintain detailed records of batch record reviews and related documentation. 📝 Participate in quality assurance audits and inspections as needed. 🕵️"â™‚️🔍 Contribute to continuous improvement initiatives to enhance batch record review processes and efficiency. 🚀 Qualifications: Bachelor's degree in a scientific discipline or related field. 🎓 Minimum of [X] years of experience in batch record review within a pharmaceutical or biotech manufacturing environment. 💼 Strong knowledge of GMP regulations, FDA guidelines, and industry best practices. 💡 Excellent attention to detail, organizational skills, and ability to work effectively in a fast-paced environment. 🌟 Strong communication and collaboration skills to work with cross-functional teams. 🗣️ Experience with electronic batch record systems is a plus. 💻 Working Conditions: This position requires 100% onsite work at our Cell & Gene Manufacturing facility in Maryland, USA. 🏢 Occasional overtime or weekend work may be required to meet project deadlines or address urgent issues. ⏰ If you are a dedicated professional with a passion for ensuring product quality and compliance, we invite you to apply for the Batch Record Reviewer position at our Cell & Gene Manufacturing facility in Maryland, USA. Join us in making a difference in patients' lives through innovative therapies. 🌟👩"ðŸ”¬ðŸ‘¨"ðŸ”¬