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Quality Control Specialist Jobs

Company

ICON
Address , Remote
Employment type
Salary
Expires 2023-07-22
Posted at 11 months ago
Job Description
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.

Needs to be onsite in West Point, PA 1-2 times a month

What will you be doing?
  • Applies project charters, project plans, and risk planning to all Standard initiatives
  • Participates in several of the following core GMSA global initiatives and assumes varying degrees of project leadership
  • Monitors the impact of any business process or regulatory changes on Standard documentation and makes the appropriate recommendation
  • Leads projects to create, maintain, review and train on Standards
  • Ensures periodic review of Standards per the divisional SOP of SOPs
  • Reviews Standards on a routine basis and revises Standards, process maps, forms, templates, guidelines, and supporting documentation when appropriate to ensure compliance with regulatory requirements
  • Collaborates with regions and countries to ensure alignment between GMSA and local Medical Affairs Standards, as appropriate
  • Manages reported quality issues and supports audits, assessments, and inspections
  • Adheres to the GMSA QMS continuous improvement methodology and supports efforts to maintain and improve Standards over time


Required Qualifications, Skills, & Experience


Needs to be onsite in West Point, PA 1-2 times a month

  • Proficiency with Microsoft Office Suite (WORD, Excel, PowerPoint)
  • Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues
  • Bachelor’s degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (e.g., Standards Alignment, Medical Operations)
  • Experience as a member in cross-functional, global initiatives in a complex matrix
  • Experience working within regulations and compliance requirements
  • Ability to work independently while escalating risks and issues as appropriate
  • Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues
  • Bachelor’s degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (e.g., Standards Alignment, Medical Operations)
  • Experience as a member in cross-functional, global initiatives in a complex matrix
  • Experience working within regulations and compliance requirements
  • Proficiency with Microsoft Office Suite (WORD, Excel, PowerPoint)
  • Ability to work independently while escalating risks and issues as appropriate