GMP Batch Record Coordinator

Batch Record Coordinator

Join our team as a Batch Record Coordinator and play a critical role in supporting GMP manufacturing operations. This position is responsible for preparing, reviewing, and maintaining batch records and controlled documentation to ensure accuracy, compliance, and operational efficiency. The ideal candidate is highly organized, detail-oriented, and thrives in a fast-paced environment where quality and compliance are top priorities.

Key Responsibilities

• Review batch records and manufacturing documentation for completeness, accuracy, and compliance with GMP and ALCOA principles.
• Prepare, issue, reconcile, and maintain controlled forms and batch production records used in manufacturing.
• Compile and organize data for investigations, quality events, corrective actions, and batch history records.
• Coordinate document revisions, approvals, distribution, and filing activities.
• Prepare manufacturing training packets and supporting documentation.
• Assemble and maintain batch record binders, labels, and production documentation.
• Track and maintain documentation quality metrics and Right First Time (RFT) performance indicators.
• Support manufacturing planning activities and collaborate with cross-functional teams to resolve documentation-related issues.
• Revise SOPs, batch production records, reports, and other controlled documents as needed.
• Perform general administrative duties, including filing, copying, scheduling, and office supply management.
• Follow all company policies, procedures, and cGMP requirements.
• Support the Senior Document Coordinator and assist with additional projects as assigned.

Qualifications

• High school diploma or GED required; additional administrative, clerical, or manufacturing experience preferred.
• Strong attention to detail and commitment to accuracy.
• Excellent organizational, written, and verbal communication skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Sense of urgency and strong problem-solving skills.
• Experience working in a regulated environment is a plus.