Quality Systems Specialist
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
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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