Document Control Coordinator

Avid Bioservices • Tustin, CA

4d • $20 - $22

About The Position

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of their clients and improve patient outcomes. As a Document Control Coordinator, you will be a vital member of the team, ensuring top-quality events and actions. This role involves compiling and reviewing data, supporting manufacturing activity planning, and swiftly resolving issues. You will coordinate controlled documents, training packets, and batch record preparation, while also managing administrative tasks and revising documents.

Requirements

• High school diploma or GED; or equivalent combination of education and experience relating administrative or clerical duties.
• Attention to detail.
• Sense of urgency.
• Excellent organization skills.
• Excellent communication skills (written and verbal).
• Adherence to timelines.
• Team player approach and positive attitude.
• Exceptional multitasking skills.
• Master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Responsibilities

• Assist in quality events and corrective and preventive actions.
• Assist in compiling and review of data for investigations, reports, and batch history records.
• 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.
• 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

• Competitive compensation packages
• Base salary
• Performance-based bonuses
• Comprehensive benefits such as health, dental, and vision insurance
• 401(k) matching
• Paid time off
• Opportunities for career growth and development
• Supportive and inclusive work environment

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 101-250 employees