Stability Scientist I

1 month ago


Deeside, Flintshire, United Kingdom ConvaTec Full time
About the Role

We are seeking a highly skilled Stability Scientist I to join our team at ConvaTec, a global medical products and technologies company. As a key member of our R&D team, you will play a critical role in ensuring the quality and safety of our medical devices and pharmaceutical products.

Key Responsibilities
  • Design, plan, and execute physical testing in support of R&D and SEG activities, adhering to ISO13485 and ISO9001 Laboratory quality system and GLP/GMP procedures.
  • Develop and validate new physical testing methods, ensuring compliance with regulatory requirements.
  • Organize and prioritize workload, ensuring the integrity of all data generated and timely provision of results to GLP standards.
  • Perform detailed laboratory investigations to determine the root cause of atypical and out-of-specification results, applying corrective and preventative actions.
  • Author validation protocols, reports, and technical documents for Medical Devices/Pharmaceutical products.
Requirements
  • Bachelor's Degree in a relevant science-related discipline.
  • Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
  • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
  • Good working knowledge of Microsoft Office, specifically Word and Excel.
About You
  • Have an understanding of the role of Physical Testing within the product development process for both new product development and existing product development of medical devices/pharmaceuticals.
  • Commands good physical testing and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of physical testing tasks to support key R&D projects.
  • Effectively communicate both oral and written scientific and technical data to peers and managers.
Working Conditions

Working in a laboratory environment with exposure to biological agents, chemicals, and reagents. Competent in the disposal of chemicals and reagents in accordance with site and environmental procedures.

Travel Requirements

There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.



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