Quality Assurance Specialist

SGS Australia Pty Ltd

Richardson, TX, United States
On-site
Ensure compliance with protocols
Maintain knowledge of gcp
Review protocols and crfs
QA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures

Job Summary

  • QA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures.
  • Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents.
  • Oversee that the lab safety and orderly contact and take prompt corrective action when unsafe conditions, practices, or equipment are reported or observed.

Matching Summary

QA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures.

Skills & Requirements

Must-have

  • Ensure compliance with protocols
  • Maintain knowledge of GCP
  • Review protocols and CRFs
  • Perform audits of study material
  • Oversee lab safety and order

Nice-to-have

  • Interpersonal skills
  • High level of multi-tasking
  • Encourage prompt reporting

Key Requirements

  • Bachelor's degree
  • 1-3 years relevant experience
  • Knowledge of GCP ICH/GLP guidelines
  • Federal Regulations related to Clinical Trials

Work Rights

Not specified

Tailored Resume

Cover Letter