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Senior Manager, Quality Assurance - Hybrid Home-Based/Cambridge, MA

Location
Harrisburg, Pennsylvania
Job Type
Permanent
Posted
7 Jan 2023
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.

What will you be doing?

The QA Research Data Assessment Associate, a member of the Research Quality Assurance organization, will be responsible for identifying, mapping and conducting in-house laboratory assessments globally across R&D to create a comprehensive mapping of in-house laboratory activities. Assess non-GxP as well as GxP laboratories for basic good research practices activities across R&D functions, (as applicable).

Developing this comprehensive assessment and mapping of all the R&D in-house laboratories will aid the R&D organization with assessing any compliance gaps and areas for process improvements. This research laboratory mapping and assessment process will include identifying the laboratory locations, laboratory walkthroughs, completing assessment tools, generating an assessment summary report identifying areas of concern and potential compliance gaps.

Under the direction of the Research Quality Assurance Lead, the person assuming this role will be expected to work with cross functional stakeholders in R&D Laboratory Operations, Scientist, Technicians, and laboratory managers, R&D functional area personnel responsible for in-house laboratory operations/activities.

The QA Research Data Assessment Associate will be an expert identify, map, and conduct in-house laboratory assessment/audits, generate a laboratory assessment report for each laboratory and a final comprehensive summary report of all laboratories identify areas of concern and potential compliance gaps. The QA Research Data Assessment Associate should have at least 8 years experience GLP, Part 11, Research Laboratory, Analytical laboratory experience as a GLP auditor, exceptional interpersonal skills, and highly organized and detailed, ability to assess non-GxP areas to good research practices standards to ensure all assessments are completed in a timely (and compliant) manner.

Must Haves:
  • Research laboratory experience, auditing experience in GLP or GCLP, Part 11, Analytical/Bioanalytical, Toxicology environments
  • Strong understanding of good research practices and data integrity
  • Organized, detail-orientated, and a self-starter
  • Ability to understand and apply fit for purpose auditing assesments
On-site to conduct laboratory assessments otherwise remote is acceptable

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Experience performing GLP audits, understanding laboratory operations.

Attention to detail in performing laboratory assessment tasks.

Experience in using Microsoft Offices products including, Word, Excel and PowerPoint.

Excellent organizational skills and the ability to handle multiple priorities and projects.

Strong organizational and communication skills

Strong written and verbal communication skills

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. Thats 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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Details

  • Job Reference: 863891471-2
  • Date Posted: 7 January 2023
  • Recruiter: ICON Strategic Solutions
  • Location: Harrisburg, Pennsylvania
  • Salary: On Application
  • Role: Data, Project Management, R
  • Job Type: Permanent