FDA-Compliant Change & Documentation Specialist

TalentBurst, an Inc 5000 company; Vista (CA); On-site; USD 33,000 - 56,000; Full time

Job summary

TalentBurst, an Inc 5000 company, is seeking a Document and Change System Specialist for a 3-month assignment in Vista, CA. The role ensures change control and document control processes comply with FDA regulations and company SOPs.

You will manage change requests, maintain the electronic document system, coordinate with cross-functional teams, and prepare documentation for reviews and approvals.

Qualifications

• Knowledge of FDA regulatory requirements for GMP.
• Strong written and verbal communication skills.
• Ability to manage multiple tasks with attention to detail.

Responsibilities

• Ensure FDA policies, SOPs and change/document control procedures are followed.
• Process change control requests for manufacturing and SOPs across sites.
• Track and manage change documentation through its lifecycle to meet deadlines.
• Coordinate with departments to deliver change information to customers and sites.
• Review content and formatting of change requests and resolve issues.
• Prepare changes for review and engage SMEs as needed.
• Perform final review of change requests and coordinate required actions.
• Maintain master libraries of change documents and SOPs.
• Manage electronic document control system and archived files.

Skills

FDA regulations / compliance

Spreadsheet

Database skills

Communication

Problem solving

Attention to detail

Independent work

Education

Bachelor's degree in a scientific field

Job description

TalentBurst, an Inc 5000 company, is seeking a Document and Change System Specialist for a 3-month assignment in Vista, CA. The role ensures change control and document control processes comply with FDA regulations and company SOPs.

You will manage change requests, maintain the electronic document system, coordinate with cross-functional teams, and prepare documentation for reviews and approvals.