Quality Assurance Analyst — Remote, Compliance & Coaching

Inizio Medical; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

Inizio Engage seeks a Quality Analyst to monitor and evaluate telephone and electronic interactions for Adverse Events, PQC, MIRs, and general inquiries, ensuring regulatory compliance and high client standards. The role drives coaching, feedback, and continuous improvement across QA initiatives.

You will identify trends, support calibration sessions, and contribute to process enhancements while safeguarding confidential information and complying with HIPAA and data privacy requirements.

Qualifications

• Bachelor's degree or equivalent education/experience.
• Knowledge of US healthcare systems, medicines regulation, and pharmacovigilance preferred.
• Experience in Medical Information, Pharmacovigilance, Patient Support Programs, healthcare call centers, or related pharmaceutical industry roles preferred.
• Internal auditing and call monitoring experience strongly preferred.
• Demonstrated proficiency in spoken and written English, with the ability to communicate professionally with U.S.-based healthcare professionals, patients, caregivers, and consumers.
• Proficiency in MS Office applications and contact center technologies.
• Ability and willingness to work schedules that support U.S. business operations, including evenings, overnight shifts, weekends, and holidays, as required.

Responsibilities

• Conduct interaction monitoring and review of documentation to ensure adherence to regulatory requirements and client guidelines.
• Identify quality and performance issues and provide coaching, feedback, and training to improve quality standards.
• Assist with implementation and enforcement of Quality and Compliance initiatives and activities as assigned.
• Participate in internal and external client audits as directed by Program Leadership.
• Score and document results of each interaction monitored in the project quality management system for timely feedback.
• Coordinate and participate in calibration sessions to promote scoring consistency and quality standards.
• Support continuous quality improvement by identifying trends and recommending corrective actions.
• Maintain confidentiality while handling sensitive information.
• Compile, analyze, and report QA metrics and recommend updates to procedures and training materials.
• Collaborate to ensure resource materials are updated for audits.
• Review signature compliance for evaluation forms and project updates to ensure timely completion.

Skills

Regulatory knowledge

Quality monitoring

Coaching and training

Auditing

English proficiency

Microsoft Office

Remote work adaptability

Analytical skills

Education

Bachelor's degree

PRC license preferred

Tools

Microsoft Office

Call center technologies

Job description

Inizio Engage seeks a Quality Analyst to monitor and evaluate telephone and electronic interactions for Adverse Events, PQC, MIRs, and general inquiries, ensuring regulatory compliance and high client standards. The role drives coaching, feedback, and continuous improvement across QA initiatives.

You will identify trends, support calibration sessions, and contribute to process enhancements while safeguarding confidential information and complying with HIPAA and data privacy requirements.