Quality Systems Specialist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Waltham, United States Ehub Global Inc Full time

Title: Quality Systems Specialist

Waltham MA

6-12 month contract

Schedule: Mon-Fri (HYBRID onsite Tues-Thurs)


2-3 years experience in biotech or another regulated industry – Required

Microsoft Suite (Word, Excel & Powerpoint) – Required

Veeva or Compliance Wire – Highly desired Highly desired


TECHNICAL QUALIFICATIONS:

·Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background

·Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility

·Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.

·Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, andthe ability to determine phase appropriate requirements

·Knowledge of Regulatory Compliance and ICH Guidelines


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