Batch Record Review - 1904031

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:

1. Review batch records for completeness and accuracy, verifying all data and documentation. ✅
2. Ensure batch records comply with SOPs, GMP guidelines, and regulatory requirements. 📋
3. Identify and address any discrepancies, deviations, or non-conformities in batch records. 🚫🔍
4. Collaborate with production teams to resolve issues and ensure timely completion of batch record reviews. 🤝
5. Maintain detailed records of batch record reviews and related documentation. 📝
6. Participate in quality assurance audits and inspections as needed. 🕵️‍♂️🔍
7. 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 3 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. 🌟👩‍🔬👨‍🔬