Senior Quality Auditor
Senior Quality Auditor
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Job Description
Job Description
Position Summary:
The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities supporting project teams during all stages of a clinical study.
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 and company policies and procedures
Additional tasks as required.
Qualifications:
Minimum Required:
4 years industry 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:
Bachelors degree in a science healthcare or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
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
Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards
Intermediate proficiency in Microsoft Word Excel and PowerPoint
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
Results oriented accountable motivated and flexible
Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
Excellent verbal and written communications skills
Fluent in English language and for non English speaking countries the local language of country where position is based
Any data provided as a part of this application will be stored in accordance with our Privacy CA applicants please also refer to ourCA Privacy Notice.
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.
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 .
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team hiring managers and a formal interview process.
Required Experience:
Senior IC
Employment Type
Full Time
