Quality Assurance Auditor II

Quality Assurance II Roles and Responsibilities:

• Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting internal and vendor audits, external audits/Regulatory Authority inspections management, SOP and documentation review and CAPA management

.• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.

• Liaise with clients and operational staff on quality aspects which may include attendance at meetings, oral presentations and audits.

• Have a thorough knowledge of all relevant SOPs, with ICH-GCP and relevant regulations and guidelines.

• Build knowledge of the company, processes and customers.

.• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance

.• 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 20%) domestic and/or international, on occasion and this may increase based on business needs.

AUDITING Responsibilities:

• Plan and conduct regular internal audits of clinical research unit and/or early phase CRO service, contract audits of ICON quality system in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines.

• Perform vendor and sub-contractor audits and follow up of previous findings.

.• Review audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.

• Ensure the audit results are formally recorded, reported, and that corrective/preventative actions are documented.

• Assist in the development of the project audit schedule.

• Verification of audit CAPA completion where required by procedure.

• *Lead the preparation, and host Sponsor audits & Regulatory Inspections of ICON

• *Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues

EXPERIENCE:

• Bachelor’s degree or relevant experience required

• 1 years experience within GCP Auditing an advantage

• 3 plus years experience working in a GCP environment

• Knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials

• Knowledge of CAPA management, including performing root cause analysis an advantage

• Experience in regulatory authority inspections an advantage

• Experience in regulatory authority inspections an advantage

#LI-MO1         

#LI-Hybrid

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.