Description
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.
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