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

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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