Document and Change System 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 is seeking to hire aDocument and Change Systems Specialist inVista, 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.