4G Careers

Quality Engineer (Analyst)
Wellesley, MA

Quality Engineer (Analyst)


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:


Responsibilities of the Quality Engineer include the following:

  • Prepare and conduct internal audits of studies, processes, and department operations.
  • Plan and write audit reports and resulting CAPAs.
  • Assist in the management of 4G Clinical CAPAs including root cause investigation, working with persons to address identified issues; drafting CAPA Summary reports for clients.
  • Review computer system validation deliverables for 4G studies and provide reports of status to management.
  • Investigate issues related to studies, data management, product usage, etc., as assigned.
  • Facilitate and manage periodic reviews of quality system documentation.
  • Assist in the management of training records and periodic training sessions.
  • Assist in the hosting of client audits and participate in all regulatory inspections.
  • Immediately escalate any suspected quality, production or process issues to Quality Management.
  • Assist in any quality initiative.

Required Experience:


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.

Other Skills/Requirements:

Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification are desirable but not required.

APPLY NOW

Sign Up For
Email Updates