ICON Clinical Research QA Auditor I- Labs in Whitesboro, New York
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The successful candidate will perform QA audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements.
Overview of the Role
Be knowledgeable with all relevant ICON SOPs, ISO 9000 requirements and with appropriate regulations and guidelines.
Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.
Perform quality system audits and perform contract audits for Sponsor as required.
Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results.
Assist with the development of the project audit procedures.
Assist in training new QA auditors and provide a benchmark of auditing competencies to inexperienced colleagues.
Assist in training ICON staff regarding GCP, ISO 9000, role of QA regulatory inspections, etc.
Conduct induction/orientation of new staff in ICON quality policies and procedures.
Assist with business development activities (such as marketing presentations) when appropriate.
Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention.* *
Role Requirements / Skills / Experience Required
BS degree in the sciences or related field or local equivalent.
Adequate experience as determined by QA Management may substitute for that requirement.
Prior experience (a minimum of one year experience) in medicine, science or other relevant disciplines.
Previous experience in a GXP quality assurance and/or research environment.
Ability to review and evaluate data / records. Good oral and written communication skills.
Ability to liaise successfully with project teams.
Competent computer skills.
Proficiency in basic Microsoft Office Suite, including Excel, Word and PowerPoint.
Additional experience in Document Management System/Data Management systems preferred but not required.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.