Position Summary:
The Senior 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: 

• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents, as required
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control process
• Provide QA 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 QA management and identify opportunities for improvement
• Maintains Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, ISO and company policies and procedures
• Additional tasks as required

Qualifications:
Minimum Required:

• Requires two to five years of applicable experience or equivalent combination of education and experience
• Clinical research experience in non-QA role considered (e.g., clinical research associate experience)
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards

Other Required:

• Bachelor’s degree in a science, healthcare, or related field of study
• Availability to travel up to 25% domestically and/or internationally

Preferred:

• CRO, Pharmaceutical and/or Medical device experience
• QA certification preferred (e.g., CQA, SQA, etc.)
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Skills: 

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

Competencies: 

• Working knowledge of GCP/ICH guidelines and FDA regulations and industry standards
• Intermediate proficiency 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
• Excellent verbal and written communications skills