Team Leader - Batch Records Review - 1977369
We are seeking a highly skilled and organized Team Leader - Batch Record Reviewer to oversee our team at the Cell & Gene Manufacturing facility in Maryland, USA. In this leadership role, you will be integral in guiding the review process of batch records to ensure the utmost accuracy and compliance with regulatory standards.
Key Responsibilities:
- Lead and manage a team of batch record reviewers, providing training and mentorship.
- Oversee the review of batch records for completeness and accuracy, ensuring all data and documentation are verified.
- Ensure team compliance with SOPs, GMP guidelines, and regulatory requirements.
- Coordinate with production teams to resolve issues swiftly and ensure the timely completion of batch record reviews.
- Maintain detailed records of batch record reviews and related documentation, ensuring accountability and traceability.
- Represent the review team in quality assurance audits and inspections.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the batch record review process.
Qualifications:
- Bachelor's degree in a scientific discipline or related field.
- Minimum of 8+ years of experience in batch record review within a pharmaceutical or biologics manufacturing environment, with at least 2 years in a leadership role, preferably with management experience.
- In-depth knowledge of GMP regulations, FDA guidelines, and industry best practices.
- Exceptional attention to detail, organizational skills, and ability to lead effectively in a fast-paced environment.
- Strong communication and collaboration skills to effectively manage and work with cross-functional teams.
- Experience with electronic batch record systems is highly desirable.
Working Conditions:
This leadership position requires 100% onsite work at our Cell & Gene Manufacturing facility in Maryland, USA.
Occasional overtime or weekend work may be necessary to meet project deadlines or address urgent issues.
If you are a driven leader who is dedicated to ensuring product quality and compliance, we invite you to apply for the position of Batch Record Reviewer Team Leader at our Cell & Gene Manufacturing facility in Maryland, USA. Join us in impacting patients' lives with innovative therapies.