Document and Change System Specialist

About the role

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

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.

Responsibilities

• 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.

Requirements

• 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.

Benefits

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

Pay

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

Skills

• Document control
• Change control
• GMP
• Electronic document control system