FDA Change Control & Documentation Specialist

Planet Pharma; Vista (CA); On-site; USD 59,000 - 65,000; Full time

Job summary

Planet Pharma is seeking a change control coordinator to ensure modifications to processes and documentation meet regulatory requirements and internal policies. You will review, justify, document, approve, and implement changes impacting safety, purity, potency, and quality in a cGMP manufacturing setting.

Your role includes coordinating change requests across plasma centers, tracking documents through their lifecycle, and ensuring timely communication with departments and customers.

Qualifications

• FDA regulatory requirements knowledge.
• Strong spreadsheet and database skills.
• Excellent written and verbal communication.
• Detail-oriented with strong organizational skills.
• Ability to work independently and manage multiple tasks.

Responsibilities

• Ensure compliance with FDA regulations and SOPs for change and document control.
• Process change control requests for CGMP manufacturing and SOPs.
• Track lifecycle of change control documentation to ensure timely completion.
• Coordinate change control to deliver requests to plasma centers and operations.
• Communicate with corporate, field management, and customers to ensure flow of information.
• Review and facilitate content and formatting of change requests with owners and reviewers.
• Prepare changes for review and engage leadership as needed.
• Perform final review and ensure evidence of impact assessments and risk management.
• Coordinate training on Change Control procedures.
• Maintain master library of change documents and secure filing system.
• Manage Quality System documentation lifecycle and distribution of specs.
• Maintain electronic document control system and archived files.
• Prepare/proof document content and formatting; coordinate with authors.
• Maintain SOPs, forms, and training docs; secure archiving.
• Maintain document control calendars and update procedures.
• Author Center Notifications to donor centers and leadership.

Skills

FDA regulatory requirements

Spreadsheet skills

Database skills

Communication skills

Detail oriented

Independent worker

Education

Bachelor’s degree in a scientific field

Tools

DCM

Job description

Planet Pharma is seeking a change control coordinator to ensure modifications to processes and documentation meet regulatory requirements and internal policies. You will review, justify, document, approve, and implement changes impacting safety, purity, potency, and quality in a cGMP manufacturing setting.

Your role includes coordinating change requests across plasma centers, tracking documents through their lifecycle, and ensuring timely communication with departments and customers.