Job Details

  • Title: Product Quality Specialist
  • Code: RCI-6851
  • Location: West Greenwich Rhode Island (RI) 02817
  • Posted Date: 01/14/2020
  • Duration: 36 Months
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  Job Description

The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations.

  • Build and maintain technical GMP documents and product stability studies
  • Review, verify, report, and archive GMP data for clinical and commercial products
  • Apply keen attention to detail to conduct data review and reports
  • Execute transactions in relevant GMP computer-based systems (change control, LIMS)
  • Adeptly manage time-sensitive activities independently
  • Business process support, such as SOP authoring and management, or gap assessments to regional regulations
Top Skill Sets:
  • Experience working in a regulated environment (either direct GMP or technical support)
  • Data Management system (lins systems) and technical writing
  • Strong project management skills
  • Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
Basic Qualifications
  • Doctorate degree, or Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
  • Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential
  • Experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
  • Experience working in a regulated environment (either direct GMP or technical support)
  • Strong project management skills
  • Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques