Senior Quality Auditor Jobs

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:

• Host client/sponsor audits and support regulatory inspections
• Maintains Q&C trackers, databases, metrics, and files
• Coordinate and conduct investigator site audits
• Support the Quality Management System including SOPs, training and CAPA
• Develop and administer training for employees and/or consultants
• 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
• Support and manage reported quality issues and any associated corrective and preventive actions
• Coordinate and conduct internal audits of quality systems
• Participate on computer systems validation projects and systems change control process
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Process and maintain documentation for controlled documents, as required
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct trial master file audits
• Provide QA consultation and support to assigned project teams internally and externally

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

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

Preferred

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

Skills

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

Competencies

• Ability to work independently and in a team environment
• Working knowledge of GCP/ICH guidelines and FDA regulations and industry standards
• Excellent verbal and written communications skills
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
• Ability to prioritize work and handle multiple and/or competing assignments
• Ability to work with cross functional groups and management under challenging situations

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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 [email protected] .