Document and Change System Specialist

R&D Partners is seeking to hire a Document and Change Systems Specialist in Vista, CA .

Your main responsibilities as a Document and Change Systems Specialist :

· Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change and document control.

· Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations, including but not limited to: product manufacturing / procedural changes, equipment changes, customer changes, supplier (contractor) changes, and facility changes.

· Tracks and maintains change control request documentation throughout its lifecycle to ensure tasks are completed in a timely manner.

· Coordinates change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations, as required.

· Communicates with other departments, including Corporate, Field management, and Center-level customers to ensure efficient flow of change requests and information pertaining to shared/impacted processes.

What we are looking for in a Document and Change Systems Specialist :

· Bachelor's degree in a scientific field

· 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, with ability to follow assigned tasks through to completion.

Why Choose R&D Partners ?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance - PPO, HMO &
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$89,440 - $97,760 Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

Desired Skills and Experience document control

change control

GMP

electronic document control system