Quality Assurance Auditor 1 Jobs

Job Overview
Assist lead auditors/audit liaisons in conducting, hosting and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QA staff.

Essential Functions

• Provide QA consultancy where possible
• Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in QA database, performing data reviews, file audits as directed.
• Support Investigators derogatory status management in the database, prepare and release guidance document with compliance information and maintain the QA repository with compliance information for investigators with derogatory status
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
• Soliciting follow-up information and closing audits/inspection findings in the QA database.
• Obtain a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques.
• Review and approval of Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans
• Entering and categorizing audit/Inspection findings in eQMS,
• Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe. Reviewing documents, identifying and calling operational staff to answer related questions. Performing required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews and coping and stamping documents for release to the auditors/inspectors.

Qualifications

• Strong interpersonal skills. Excellent problem-solving skills.
• Ability to manage multiple projects.
• Effective organization, communication, and team orientation skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to initiate assigned tasks and to work independently.
• Bachelor's Degree preferred
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.
• 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.