Quality Analyst (m/w/d)

Ashfield Healthcare; United States; Remote; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Analyst to ensure compliance with regulatory standards and client guidelines. In this pivotal role, you will monitor adverse events and product quality complaints, providing essential feedback and coaching to enhance team performance. Your expertise in quality assurance will help implement initiatives and maintain high-quality standards across client programs. Join a supportive team that values proactive communication and collaboration, and enjoy a flexible working environment with excellent remuneration. This is a fantastic opportunity to make a significant impact in a dynamic field.

Benefits

Flexible working hours

Friendly working atmosphere

Well above industry average remuneration

Qualifications

• Bachelor’s degree in Life Sciences or equivalent experience required.
• Quality audit and monitoring experience preferred.

Responsibilities

• Monitor AE and PQC reports to ensure adherence to guidelines.
• Conduct interaction monitoring and provide feedback to improve quality.
• Assist with internal and client audits as directed.

Skills

Communication Skills

Organizational Skills

Time Management

Attention to Detail

Interpersonal Skills

Coaching Skills

Education

Bachelor’s Degree in Life Sciences

Tools

Inizio Quality Management System (QMS)

Job description

Conduct interaction monitoring which includes the review of telephone and electronic interaction containing Adverse Events (AE), Product Quality Complaints (PQC), Medical Information Request (MIR) and General Inquiry cases completed by Inizio Engage staff to ensure adherence to regulatory requirements and specific client guidelines. Identify quality and performance issues, and along with Program Leadership and Quality & Compliance, provide feedback and coaching to train team members and improve quality standards. Assist with identifying and implementing quality initiatives. Assist with Quality Assurance (QA) implementation and enforcement as assigned, including conducting and tracking the completion of internal audits.

Quality Analyst (m/w/d)

Key Responsibilities:

• Monitor AE and PQC reports/cases and narratives to ensure adherence to regulatory requirements and client guidelines.
• Maintain excellent quality and productivity standards for all client programs; adhere to program scripts and guidelines.
• Conduct interaction monitoring for assigned Program(s). Exhibit effective communication and tele-management skills.
• Document and score the results of each report/case review and interaction monitoring in the Inizio Quality Management System (QMS) in order for staff to receive timely feedback.
• Coordinate and track monitoring activity with Manager, Project Training and Quality or designee.
• Work with Program Team to ensure AE and PQC reports/cases are submitted within the specified timelines required by the client.
• Support one-on-one coaching, in collaboration with Program Leadership, to staff regarding AE & PQC report/case review results.
• Participate in discussions with Project Leadership relative to project requirements and product and safety knowledge.
• Work with team to run quality reports and collect Key Performance Indicators (KPIs) at required frequency.
• Work as a team to improve processes and procedures and perform ad hoc projects with program leadership. This may include, amongst other things, development of processes, reports and guidelines to ensure the successful delivery of services.
• Create and maintain client-specific documentation and standard operating procedures (SOPs).
• Participate in internal and client calibration sessions.
• Assist with internal and client audits as directed, including corrective action/preventative action work associated with any findings and observations.
• On occasion other duties as assigned.

Job Holder Specification:

• Bachelor’s Degree in Life Sciences or equivalent work related experience.
• Quality related audit and monitoring experience is preferred.
• Training and coaching experience is preferred.
• Excellent written and verbal communication skills.
• Excellent organisational and time management skills.
• Enjoy working proactively with the ability to work towards deadlines.
• Attention to detail and the ability to follow process diligently.
• Good interpersonal skills and relationship building capability.
• Strong work ethic.

OUR OFFER:

• Remuneration: well above the industry average in a permanent employment relationship.
• Working hours: Flexible working hours according to project requirements.
• An excellent working atmosphere with friendly and helpful colleagues.

WE ARE LOOKING FORWARD TO MEETING YOU.

If you have any questions, please call Elisa Aasen at 0152 - 21864396.

Internal reference number: 21316.

Please apply online.