Sr. Quality Control Auditor (Home/Office-Based) - IQVIA Biotech, Mexico

POSITION TITLE:                     Senior Quality Control Auditor

REPORTS TO:                             Manager/Senior Manager, Quality Control or Designee

BASIC FUNCTION:

Serve as a Sr. Quality Control auditor to develop and maintain quality control validation programs to review all client deliverables produced by the Data Operations team (Data Management, Clinical Programming, SAS Programming, and Biostats).  Also, serves as a mentor to Quality Control Auditors.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Responsible for quality control processes relating to customer deliverables for the Data Operations team.
  • Electronic Database Capture (EDC) system validation (InForm, Rave, IBM CD, Viedocs) based on Data Management/Programming specifications.  The EDC components typically include eCRF design, EDC Administration/Configuration settings, Edit Checks, Data Integrations.
  • Understand and execute Quality Control validation template instructions / test plans to validate EDC system components against Data Management / Programming specifications, e.g. eCRFs, Edit Checks, Patient Profile reports, Ad Hoc reports, etc.
  • Communicate validation findings / observations to Data Management and Programming following completion of the validation task and communicate potential improvements if needed.
  • Work with team to revalidate the component(s) once Data Management and Programming update specifications (if needed) and make programming updates.  The QCA will continue to work with Data Management and Programming to support the validation task through cycles of rework/revalidation until the component passes validation.
• Assure detailed and quality documentation practices adhered to for the Quality Control validation documentation to support customer and regulatory audits.
• Conduct project QC documentation and eTMF project audits.
• Assist with the evaluation of quality control processes.
• Assure process compliance with all regulatory and IQVIA Biotech SOPs.
• Assist in the scheduling and coordination of all QC activities across projects.
• Mentor Quality Control Auditors on quality processes and advise on documentation.
• Assure QC documentation for each project are audit ready and uploaded to eTMF per the IQVIA Biotech SOPs.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process and methodology.
• Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
• Excellent organization, communication, documentation, and computer skills
• In-depth knowledge of quality control processes and procedures.
• Ability to act independently and with initiative required to resolving problems.
• Ability to pay careful attention to details and deliver quality work with a high degree of accuracy within expected timelines.
• Ability to mentor others.

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree or equivalent and 2 years experience performing quality control functions
• Equivalent combination of education, training and experience 

CLASSIFICATION (US):

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.