Ashfield Healthcare

Job Title: Quality Analyst
Project/Team/Department: Medical Information
Reports To: Manager/Senior Manager Quality & Training
Direct Reports: None
Location: Inizio Engage hub office / Remote

Job Purpose/Overview:

The Quality Analyst will conduct monitoring of interactions, including telephone and electronic communications involving Adverse Events (AE), Product Quality Complaints (PQC), Medical Information Requests (MIR), and General Inquiry cases managed by Inizio Engage staff. The primary focus will be to ensure compliance with regulatory standards and client-specific guidelines. The role involves identifying quality and performance issues and collaborating with Program Leadership and Quality & Compliance teams to provide feedback and coaching to enhance team performance. The Quality Analyst will also assist in identifying and implementing quality initiatives and participate in the implementation and enforcement of Quality Assurance (QA) measures, including conducting and tracking internal audits.

Roles & Responsibilities:

• Monitor AE and PQC cases to ensure compliance with regulatory requirements and client guidelines.
• Conduct interaction monitoring for assigned programs.
• Document and score results of report/case reviews and interaction monitoring in the Inizio Quality Management System (QMS) for timely staff feedback.
• Coordinate and track monitoring activities with the Manager, Project Training and Quality, or designee.
• Collaborate with the Program Team to ensure timely submission of AE and PQC reports/cases as per client timelines.
• Provide one-on-one coaching to staff on AE & PQC report/case review results in partnership with Program Leadership.
• Engage in discussions with Project Leadership regarding project requirements and product and safety knowledge.
• Collaborate with the team to generate quality reports and collect Key Performance Indicators (KPIs) at the required frequency.
• Work with the team to enhance processes and procedures and undertake ad hoc projects with program leadership, including developing processes, reports, and guidelines.
• Create and maintain client-specific documentation and Standard Operating Procedures (SOPs).

Requirements & Qualifications:

• Bachelor’s Degree in Life Sciences or relevant work experience.
• Previous experience in quality-related audits and monitoring is preferred.
• Experience in training and coaching is a plus.

Why Join Us?

At Inizio, we provide a fast-paced, rewarding environment where your contributions truly make a difference. Whether you're in the field or working remotely, we are committed to supporting your career growth at every stage. With a focus on improving patients' lives, this role offers you the opportunity to make meaningful contributions while enhancing your skills and career.

We are dedicated to fostering a diverse and inclusive workplace. Employment at Inizio is based on merit and business needs, without discrimination.

Ready to Make a Difference? Apply today!

Please Note: If you have not heard from us within 7 days, your application has been unsuccessful at this stage.