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QA Specialist II/Senior Quality Specialist

009661_2

About the role

This vacancy has now expired. Please click here to view live vacancies.

Are you interested in joining ICON as a subject matter expert in conducting regulatory compliance audits, driving CAPA’s, developing SOP’s and integrating corporate quality management systems?
 
Quality Assurance Specialist (Level II – Senior) role within ICON: 
ICON Clinical Research has a strong reputation in our approaches to clinical development and provides innovative strategies to the drug development process. Quality Assurance Specialistwork closely with QA Management, internal/external clients and vendors or suppliers of ICON.  You will develop and manage SOP’s while also reviewing and approving Systems Development Life Cycle Role (SDLC) documentation to assure regulatory compliance.
 
ICON is presently in over 40 countries with over 80 offices worldwide and over 10,000 employees globally. In this role you will assess system related procedures for data collection relative to clinical study protocol. Review of documentation related to study protocol and procedures.
 
 
Benefits of working at ICON:
We provide our Quality Assurance Specialist a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance.  Additionally, we have cutting edge technology that will allow you to analyse study specific processes/documentation, audit reports, and governance to quality system checks and ensure compliance.
 
To succeed you will need:
We are seeking a bachelor’s degree and at least 3 years of Quality Assurance experience with a strong working knowledge of GCP, ICH and QA Principles. Successful candidate will have experience within a Pharmaceutical, Biotech company or CRO. One will need to have a working knowledge of both SDLC methodology and 21CFR Part 11 including the auditing against the regulation. In order to travel we may require a valid driver’s license and the willingness to travel up to 10% when needed.
 
We invite you to review our opportunities at www.iconplc.com/careers.

What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
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