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ICON Strategic Solutions Quality Assurance Associate - Audit Operations in Boston, Massachusetts

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

  • Support audit, inspection, deviation and CAPA management activities by developing standards, providing training and managing records in the quality management system (i.e., Trackwise)

  • Support special projects with relevant stakeholders in quality and research and development and ensure successful completion

  • Track and manage open actions stemming from various meetings (i.e., leadership meetings, project meetings, supplier meetings, etc.)

  • Support the development of standards such as procedures, job aids, tools, checklists, etc. and provide training on the conduct of audits, inspections, deviations and CAPA management

  • Manage audit, inspection, deviation and CAPA records in the quality management system (i.e., Trackwise)

  • Develop innovative presentations and trainings for management

  • Utilize project management skills to support special projects with relevant stakeholders in quality and research and development by facilitating meetings, following up on action items, creating and managing documents and ensuring adherence to timelines

  • Maintain meeting minutes, manage open actions and ensure successful completion of actions stemming from various meetings (i.e., leadership meetings, project meetings, supplier meetings, etc.)

  • Review, analyse and report on trends stemming from audits, inspections, deviations and CAPAs

  • Escalate systemic and/or critical findings to the Head of GCP Compliance and CQA management

  • Support with logistics during inspections such as request tracking and document coordination

  • Support other compliance support activities, as required

  • BA/BS degree required. Degree in scientific discipline preferred

  • Minimum of 2 years of experience in the pharmaceutical, biotechnology or related health care industry

  • Minimum 1 years of GCP-related Quality Assurance or relevant clinical trial experience

  • Knowledge and experience in GCP, quality, and compliance to conduct responsibilities with input and direction, as needed, from supervisor and other CQA team members

  • Understanding of GCP audit conduct and reporting an advantage

  • Collaborative team player with a positive attitude that desires to learn and develop in CQA

  • Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.

  • Able to prioritize and manage multiple projects and demanding timelines

  • Attention to detail and ability to analyse complex data Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, 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.

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