Quality Auditor I

Employer
Advanced Clinical
Location
Deerfield, United States
Salary
Competitive
Closing date
4 Oct 2020

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Discipline
Quality, Auditor
Hours
Full Time
Contract Type
Permanent
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A dvanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

With direction and oversight from the Head of Compliance and Quality, the Quality Auditor I provides support (which may include planning/conduct/follow-up) for internal audits/assessments, vendor assessments/audits, hosting client audits and supporting other quality department activities (inspection support, SOP writing/editing, etc.). The Quality Auditor I may also provide assistance to other auditors.
  • Provides support (which may include planning/conduct/follow-up) for client audit activities
  • Provides support (which may include planning/conduct/follow-up) for internal audits/assessment activities
  • Provides support (which may include planning/conduct/follow-up) for vendor assessment/audit activities
  • Updates the applicable quality department tracking tools and repositories as required
  • Provides support for other quality department activities, including inspection support, SOP writing/editing, etc.
  • Provides support to other quality department staff, to include various co-auditing activities, as directed by management
  • Acquires knowledge of applicable regulations, including Good Clinical Practices and other relevant US and international regulations
  • Bachelor's or equivalent degree in a relevant field of study (Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is preferred
  • Applicable quality assurance, regulatory, or clinical research-related training is preferred
  • Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
  • At least two years of experience in quality assurance, clinical research, regulated industry experience, and/or equivalent is preferred
  • Candidate must demonstrate proficient writing skills, be a good communicator, have good organizational skills, and be proficient with applicable software systems
  • Travel up to 10% may be required

What's in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

Our Culture: https://careers.advancedgroup.com/embrace-our-culture

Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

Community Programs: https://careers.advancedgroup.com/unleash-your-passion

For a complete list of all of our job openings, please visit Advanced Group's career site here .

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience: http://www.advancedclinical.com

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  • United Kingdom
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