QA Auditor II

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Summary:

This role would suit best for ICON CRAs or TMFO members or team members with experience in eTMF handling (e.g. review of TMF documents, retrieving TMF documents, familiar with TMF inventory). The role would be focusing on doing contracted independent QA TMF audits (Quality Control tasks/checks are not included in this role tasks) but also other contracted QA audit could be assigned as applicable. A comprehensive training will be delivered to the candidate to develop on auditing skills not limited to TMF audit.

Job Description:

• Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defense, case management and CAPA management.

· Assist in training new Auditors.

· Be familiar with all relevant SOPs, and with appropriate regulations and guidelines. * Work within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.

· Responsible for escalating quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.

· Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance. Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.

AUDITING Responsibilities:

· Plan and conduct regular contracted internal audits and for cause audits of the ICON quality system in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines. The role will be primarily focused on conducting Trial Master File (TMF) audits. Other audit types may be assigned, a comprehensive training will be delivered to the candidate to develop audit skills not limited to TMF audits

· Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management.

· Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.

· Assist with the development of the project audit procedures and scheduling of work.

· When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the operations and/or operational lead on all QA issues, including audit planning and review of audit results.

· Keep the person to whom the QA Auditor reports to informed of any QA issues within the department that require attention.

· Perform structured work assignments for Internal Audit Program.

· Perform vendor and sub-contractor audits.

· Verification of audit CAPA completion where required by procedure.

CAPA MANAGEMENT:

· Liaise with the client, providing input on CAPA plans and o Ensure ICON's QMS/ tracking system updated with the appropriate information and documentation.

• Lead CAPA management for internal & external audits & inspections including: o RCA and investigation meetings with relevant operational responsible persons, o Liaise with the Sponsor and/or Regulator. o Provide input on CAPA plans. 0 Ensure ICON's QMS/ tracking system updated with the appropriate information and documentation.

· Assist with the tracking of incoming QIs and QI triage and assessment process.

· Determine effectiveness check requirements for responsible CAPA, track and complete effectiveness checks as required. * Assist with the review of effectiveness check requirements, effectiveness check plans and effectiveness check outcomes.

GOVERNANCE Responsibilities:

· Support quality and regulatory compliance and escalation management processes including ensuring the timely escalation of suspected scientific misconduct and potential serious breach notifications.

· Assist with case management of suspect scientific misconduct, risk cases & potential serious breach investigations.

· Assist ongoing investigations based on the specifics of each individual case in a structured manner and as per relevant work instructions.

· Provide ongoing updates on actions and results as needed to the core investigation team and relevant senior management across ICON including Quality & Compliance. Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.

· Generate and distribute internal case summaries for GRC Management.

· As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

· Travel (up to 35%) domestic and/or international on occasion if needed.

• Other duties as assigned

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.