Batch Record Coordinator

Role Overview

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: Become a vital member of our team as a Batch Record Coordinator, ensuring top-quality events and actions.

Responsibilities

• Compile and review data, support manufacturing activity planning, and swiftly resolve issues.
• Cook up and manage administrative tasks and revise documents.
• Coordinate controlled documents, training packets, and batch record preparation.
• Communicate with Manufacturing staffs, supervisors, and members of other departments, as appropriate, to ensure prompt resolution of problems.
• Oversee timelines for document revision and sign off.
• Collect, submit, and file controlled documents.
• Prepare, issue, maintain and reconcile controlled forms used in Manufacturing.
• Cook up Manufacturing training packets and associated forms (batch production records, BSS, planned QEs) when applicable.
• Prepare binders with associated batch records, forms and labels required for production processes or formulations.
• Create and maintain RightFirstTime (RFT) and documentation quality metrics, including trends on corrections, GDP deficiencies, and data integrity performance.
• Review records for completeness.
• Follow company policies and procedures.
• Assist Sr. Document Coordinator.
• Prepare and compile GMP Batch History Record Binders.
• Issue and reconcile controlled forms used in Manufacturing.
• Make editorial changes to controlled documents and reports.
• Distribute controlled documents (Doc Control).
• Perform general administrative responsibilities – making copies, filing, scheduling and ordering office supplies.
• Revise Batch Production Records, SOPs, and other controlled documents.
• Perform other tasks as assigned.

Qualifications

• High school diploma or GED; or equivalent combination of education and experience relating to administrative or clerical duties.
• An attention to detail.
• A sense of urgency.
• Excellent organization and communication skills (written and verbal).
• Adherence to timelines.

Position Details

This role is a full-time position. Days of work are Monday through Friday. Must be available to work holidays, weekends, or extended hours when needed.

Compensation

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $16.68 to $22.26 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

About the Company

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.