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Senior Quality Auditor – REMOTE

Precision For Medicine

This is a Contract position in Las Vegas, NV posted September 21, 2022.

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 Any data provided as a part of this application will be stored in accordance with our Privacy Policy .

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 .