FDA-Compliant Change & Document Control Specialist

R Dpartners; Vista (CA); On-site; USD 89,000 - 98,000; Full time

Benefits offered by this job

Medical insurance – PPO, HMO &

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval

Job summary

R&D Partners seeks a Document and Change Systems Specialist in Vista, CA. You will ensure FDA cGMP compliance of change and document control processes across plasma centers and operations.

You will process change control requests, track documentation through lifecycle, coordinate with Corporate, Field management, and customers to ensure timely delivery of information and adherence to SOPs. The role requires a scientific degree and strong communication skills.

Qualifications

• Bachelor’s degree in a scientific field.
• Strong knowledge of FDA regulatory requirements for good manufacturing practices (cGMP).
• Demonstrated spreadsheet and database computer software skills.
• Excellent oral and written communication skills.
• Strong problem solving skills, with ability to follow assigned tasks through to completion.

Responsibilities

• Ensures compliance with FDA regulations and SOPs related to change and document control.
• Processes change control documentation for cGMP manufacturing processes and SOPs for plasma centers and operations.
• Tracks and maintains change control documentation through its lifecycle.
• Coordinates change control to ensure timely delivery of requests and information to customers (plasma centers and operations).
• Communicates with Corporate, Field management, and Center-level customers to ensure efficient flow of change requests.

Skills

Spreadsheet skills

Database software

Oral and written communication

Problem solving

Education

Bachelor’s degree in a scientific field

Tools

Spreadsheet software

Database software

Job description

R&D Partners seeks a Document and Change Systems Specialist in Vista, CA. You will ensure FDA cGMP compliance of change and document control processes across plasma centers and operations.

You will process change control requests, track documentation through lifecycle, coordinate with Corporate, Field management, and customers to ensure timely delivery of information and adherence to SOPs. The role requires a scientific degree and strong communication skills.