Senior GCP Quality Auditor - REMOTE

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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$76,500—$110,200 USD

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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

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