Batch Record Coordinator
About The Position
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? 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. You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also managing administrative tasks and revising documents. Ready to make a big impact? This role is for you! Assist in quality events and corrective and preventive actions. Assist in compiling and review of data for investigations, reports, and batch history records. Reviews executed batch records for completeness, accuracy, and adherence to ALCOA principles, ensuring all GMP documentation meets internal and regulatory standards. Support Manufacturing activity planning. 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. Coordinate and prepare 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. Creates and maintains 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. Perform duties per cGMP guidelines. 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). General administrative responsibilities – making copies, filing, scheduling and ordering office supplies. Revise Batch Production Records, SOPs, and other controlled documents. Other tasks may be assigned as needed.
Requirements
- High school diploma or GED; or equivalent combination of education and experience relating to administrative or clerical duties.
- Attention to detail.
- Sense of urgency.
- Excellent organization and communication skills (written and verbal).
- Adherence to timelines.
Responsibilities
- Assist in quality events and corrective and preventive actions.
- Assist in compiling and review of data for investigations, reports, and batch history records.
- Reviews executed batch records for completeness, accuracy, and adherence to ALCOA principles, ensuring all GMP documentation meets internal and regulatory standards.
- Support Manufacturing activity planning.
- 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.
- Coordinate and prepare 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.
- Creates and maintains 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.
- Perform duties per cGMP guidelines.
- 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).
- General administrative responsibilities – making copies, filing, scheduling and ordering office supplies.
- Revise Batch Production Records, SOPs, and other controlled documents.
- Other tasks may be assigned as needed.
Benefits
- health, dental, and vision insurance
- 401(k) matching
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
101-250 employees
