Change Control Coordinator

We are looking for a Change Control Coordinator to support several ongoing projects. This role is hybrid with the location in San Rafael, CA.

Responsibilities

Change request vetting, creation, coordination, tracking and closeout

• Receive and review all change requests submitted related to the project
• Facilitate initial assessments to determine the potential impact of the change
• Document all change requests and related activities within QMS
• Maintain complete and accurate records of all change control activities, including meeting minutes, assessments, approvals and implementation plans
• Coordinate the review and approval process with relevant stakeholders
• Track the progress of change requests through the approval workflow and QMS
• Resolve or escalate any issues or discrepancies that arise during the review and approval process
• Monitor the implementation of approved changes
  
  

QMS documents creation, coordination from draft to approval

• Author, review, and edit various types of technical documents
• Ensure compliance with QMS/DMS functionalities and best practices
• Leverage QMS/DMS features for version control, change history tracking, and electronic signatures
• Ensure all documents are accurate, complete, concise, and compliant with relevant regulations
• Adhere to writing style guides and templates
• Coordinate document review meetings
  
  

Ensure compliance with all relevant SOP's and regulations

Education And Qualifications

• Bachelor's degree and a minimum of 5 years experience with change control activities in a regulated environment
• Ability to complete multiple tasks as assigned.
• Proven organization skills.
  
  

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.