Change Control Systems Specialist

Jobtailor; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor seeks a Change Control Specialist to manage regulatory-compliant change control processes within FDA/cGMP frameworks. You will coordinate documentation, reviews, and approvals across plasma center operations and manufacturing teams.

The role emphasizes attention to detail, strong communication, and the ability to work independently while prioritizing tasks to meet regulatory timelines in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific field.
• Typically requires 5 years of related experience.
• Strong knowledge of FDA regulatory requirements for cGMP.
• Demonstrated spreadsheet and database software skills.
• Excellent oral and written communication skills.
• Strong problem solving skills.
• Attention to detail.
• Ability to prioritize and work independently with limited supervision.

Responsibilities

• Process change control requests to ensure review, justification, documentation, and implementation per regulatory requirements.
• Ensure compliance with FDA regulations and cGMP SOPs related to change control.
• Handle change control documentation for plasma centers and operations.
• Track lifecycle of change control requests from creation to closure.
• Coordinate change control processes to ensure timely delivery to customers.
• Communicate with departments to maintain flow of change requests.
• Prepare changes for review and engage leadership and SMEs as needed.

Skills

Spreadsheet skills

Database skills

Oral and written communication

Problem solving

Attention to detail

Independent work

FDA regulatory knowledge

Education

Bachelor's degree in a scientific field

Tools

Microsoft Excel

Database software (SQL/Access)

Job description

Responsibilities

• Processes change control requests to ensure that process and documentation changes are thoroughly reviewed, justified, documented, and implemented in conformance with regulatory requirements.
• Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change control.
• Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and operations.
• Tracks and maintains change control request documentation throughout its lifecycle: creation/revision, review and approval, implementation, closure.
• Coordinates change control process to ensure timely delivery of change requests and information to customers.
• Communicates with other departments to ensure efficient flow of change requests.
• Prepares changes for review and engages leadership and subject matter experts as needed.

Requirements

• Bachelor's degree in a scientific field.
• Typically requires 5 years of related experience.
• Strong knowledge of Food and Drug Administration (FDA) regulatory requirements for good manufacturing practices.
• Demonstrated spreadsheet and database computer software skills.
• Excellent oral and written communication skills.
• Strong problem solving skills.
• Attention to detail.
• Ability to prioritize and work independently with limited supervision.

Core Competencies

Demonstrates expertise in managing change control processes in compliance with FDA regulations and cGMP manufacturing practices. Proficient in documentation management, communication across departments, and problem‑solving with a strong attention to detail.