Senior Quality Assurance (QA) Auditor, Genomics Laboratory

@ 5TA US Quintiles Laboratories
5TA US Quintiles Laboratories5tausquintileslaboratories.com

Senior Quality Assurance (QA) Auditor, Genomics Laboratory

Durham, NC
Posted 6 days ago

About the job

IQVIA Laboratories, a leader in healthcare research and solutions, seeks a Senior QA Auditor to assess compliance, support audits, and enhance quality in a genomics lab environment.

Requirements

  • 5 years in pharma or related fields
  • 3 years in Quality Assurance
  • GXP experience
  • Knowledge of R&D processes
  • Experience with audits and quality systems

Qualifications

  • Bachelor's degree preferred
  • Strong problem-solving skills
  • Excellent communication abilities
  • Organizational skills
  • Ability to work independently

Full job description

We are seeking Senior QA Auditor, Genomics Laboratory to join IQVIA Laboratories at Durham, NC.
We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.
 

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.
If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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.
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