IQVIA

Senior Quality Assurance (QA) Auditor, Genomics Laboratory

IQVIA • $75K — $188K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree preferred, or equivalent experience.
  • 5 years in pharmaceutical or related area, 3 years in Quality Assurance.
  • Experience with GXP compliance and audits.
  • Knowledge of pharmaceutical research and development processes.
  • Proficiency in eQMS and standard office applications.

Responsibilities

  • Plan, schedule, conduct, and close quality audits.
  • Review audit findings and communicate results to stakeholders.
  • Provide guidance on regulatory compliance and quality standards.
  • Support RCA, CAPA, and quality investigations through closure.
  • Host customer audits and regulatory inspections.
  • Maintain eQMS and support quality event management activities.
  • Lead quality improvement initiatives and process optimization projects.

Benefits

  • Comprehensive health and wellness programs.
  • Support for physical, mental, emotional, and financial well-being.
  • Integrated benefits programs tailored to employee needs.
  • Resources for employees' well-being journey.
Full Job Description
We are seeking Senior QA Auditor, Genomics Laboratory to join IQVIA Laboratories at Durham, NC.

Job Summary:

Plan and conduct independent quality audits to assess compliance with applicable regulations, guidelines, customer requirements, and operating procedures within laboratory and research environments. Provide expert consultation on compliance matters, support quality improvement initiatives, and help maintain the highest standards of regulatory readiness and operational excellence.

What You'll Be Doing:
  • Plan, schedule, conduct, and close audit activities to evaluate compliance with regulations, guidelines, customer requirements, and company procedures
  • Review audit findings, prepare reports, and communicate results to operational teams, management, and clients
  • Provide guidance on regulatory requirements, quality standards, compliance status, and procedural interpretation
  • Support investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and effectiveness checks through to closure
  • Host and support customer audits, mock inspections, and regulatory inspections
  • Maintain and support electronic Quality Management System (eQMS) activities and quality event management
  • Lead or contribute to quality improvement initiatives, process optimization projects, and compliance programs
  • Assist with onboarding and training of Quality Assurance personnel
What We Are Looking For:
  • A Bachelor's Degree is preferred.
  • 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance.
  • GXP experience.
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environments
  • Knowledge of quality assurance processes and procedures and experience supporting audits, inspections, and quality systems
  • Proficiency with word-processing, spreadsheet, database applications, and electronic Quality Management Systems (eQMS)
  • Other equivalent combination of education, training, and experience may be accepted in lieu of degree


The Knowledge, Skills and Abilities Needed for This Role:
  • Strong problem-solving, risk analysis, negotiation, and decision-making skills
  • Excellent organizational, communication, interpersonal, and team collaboration abilities
  • Ability to work independently, manage multiple projects simultaneously, and build effective working relationships with colleagues and clients
  • Strong training and coaching capabilities
  • Ability to evaluate compliance risks and recommend continuous process improvements


What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

Keep Up to Date

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Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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