Senior QA Auditor II - Remote Compliance & Audits

Lifelancer Ltd; United States; Remoto; USD 9500 - 16.000; Tempo pieno

Descrizione del lavoro

IQVIA is a leading global provider of clinical research services and healthcare insights. The QA Auditor 2 role supports audits, CAPA, and regulatory inspections across international projects, advising on regulations and quality systems.

You will contribute to QA initiatives, train staff, and help sustain compliance with GXP standards. The position emphasizes collaboration with operations and clients, enabling proactive risk management and process improvements within a remote work setup.

Competenze

• 4+ years in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.
• Strong interpersonal skills. Excellent problem solving skills.
• Effective organization, communication, and team orientation skills.

Mansioni

• Plan, schedule, conduct, report and close audit activities in IQVIA contracts to assess compliance with applicable regulations/guidelines, SOPs and project guidelines.
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations, compliance status, and policies and procedures.
• Provide consultation to customers and monitors in interpretation of audit observations.
• Host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.

Conoscenze

GXP regulations

QA auditing

Regulatory compliance

Interpersonal skills

Formazione

Bachelor's Degree Pref

Descrizione del lavoro

IQVIA is a leading global provider of clinical research services and healthcare insights. The QA Auditor 2 role supports audits, CAPA, and regulatory inspections across international projects, advising on regulations and quality systems.

You will contribute to QA initiatives, train staff, and help sustain compliance with GXP standards. The position emphasizes collaboration with operations and clients, enabling proactive risk management and process improvements within a remote work setup.