GCP Quality Auditor (Remote)

Position Summary:
The Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. 

Essential functions of the job include but are not limited to: 

• Process and maintain controlled documents
• Jointly develop and administer training for employees and/or consultants
• Jointly host client/sponsor audits and support regulatory inspections
• Jointly coordinate and conduct assessments/audits of vendors
• Jointly coordinate and conduct internal audits of quality systems
• Jointly coordinate and conduct investigator site audits
• Jointly coordinate and conduct trail master file audits
• Participate in computer systems validation project and systems change control process
• Provide Quality consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive 
  actions
• Monitor quality systems to provide feedback on compliance risks to Quality management and 
  identify opportunities for improvement
• Maintain Quality trackers, databases, metrics, and files, as required
• Follow applicable regulations and standards, including but not limited to local regulations (US 
  FDA and EU) ICH, ISO and Precision policies and procedures

Other duties as assigned
Qualifications:
Minimum Required:

• 1+ years industry experience
• GCP familiarity

Other Required:

• Availability to travel up to 25% domestically and/or internationally

Preferred:

• CRO, Pharmaceutical and/or Medical device experience
• Auditing experience
• Familiarity with Precision SOPs, ICH-GCP and applicable regulations
• Clinical research knowledge

Skills: 

• Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills

Competencies:

• Experience in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or 
  similar database
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, 
  and a keen attention to detail
• Ability to work independently and in a team environment
• Ability to work with cross functional groups and management under challenging 
  situations
• Ability to prioritize work and handle multiple and/or competing assignments