QA Associate

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.

SUMMARY

•             Coordinate the processing of quality issues to ensure that quality issues are data entered, reported and documented in accordance with internal and or sponsor requirements.

•             Perform data analysis, and generate reports in order to determine trends, evaluate risk, and identify areas of improvement.

•             Work with direct line manager or designee to:

o             Develop processes in line with changing business needs to ensure process improvement

o             Mentor new and less experienced Associates on the quality issue processes.

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EXPERIENCE

•             To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•             A minimum of 1 year administrative experience in the pharmaceutical industry.

•             Strong technical skills, including proficiency in MS Office applications, with emphasis in Excel.

•             Ability to work independently and prioritize work based on own judgement with minimal supervision.

•             Excellent organizational, verbal and written communication skills.

•             Ability to prioritize, multi-task and work independently with time-sensitive material.

•             Meticulous attention to detail.

•             Proven experience with client interaction.

•             Excellent customer service skills.

•             Ability to contribute effectively within a team environment.

Thorough understanding of management confidentiality (in relation to both project and personnel information).

RESPONSIBILITIES

•             Recognize, exemplify and adhere to ICON's values which centers 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.

•             As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

•             Travel (approximately 0%) domestic and/or international

Support the processing of quality issues

•             Monitor quality issue mailbox daily - secure coverage for out of office.

•             Prepare required quality issue reports for delivery to sponsor mailbox.

•             Organize and schedule quality issue meetings and record the minutes of those meetings.

•             Create and support the maintenance of the associated quality issue records.

•             Adequately track all quality issue records on associate tracking documents.

•             Participate in sponsor meetings regarding quality issue process.

•             Provide innovative suggestions and possible solutions for new and/or enhanced reports, ad-hoc report process and end-user requirements to improve quality and effectiveness of quality issue reporting.

SUPERVISION/TRAINING

•             Assist with training and mentoring new and less experienced associates, including the identification of supplemental training needs.

About ICON

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries and is one of Ireland’s most successful indigenous companies. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates in 38 countries and has approximately 12,000 employees.

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. Applications will close on September 30th, 2014. This position is open to EU passport holders and Stamp 4 visa holders.