4G Clinical, a cutting-edge Randomization and Trial Supply Management company, has immediate an opening for a full-time Quality Engineer (Analyst) in our Wellesley, Massachusetts Office.
Responsibilities of the Quality Engineer include the following:
The position will require knowledge of software development and technology as it relates to process. Demonstration in the ability to plan and conduct projects independently. Ability to take initiative with direction and follow through on several tasks/projects at once. Experience in a software development company supporting regulated clinical trials is highly desired, as well as strong understanding of software development and computer systems validation. The ideal candidate will possess a working knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11), and EU Annex 11, GDPR, or GAMP 5, however, we are willing to train in these skills.
Education and/or Certification Requirements:
The candidate must possess at minimum a bachelor’s degree in a life sciences, or information technology field, or equivalent experience.
Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification are desirable but not required.