Demo

Quality Systems Specialist

Advantage Technical
MA Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/2/2025

Position : Quality Systems Specialist

Location : Cambridge, MA (Hybrid preferred)

Type : Temp to Hire (Not available for C2C)

M-F 40 HOURS

Overview :

Support key quality processes (Deviation, CAPA, Change Control, Regulatory Intelligence, and Training) in a global biotech environment, ensuring compliance and efficiency.

Responsibilities :

  • Support global quality processes (Deviation, CAPA, Change Control, Reg Intel, Training).
  • Analyze quality metrics and performance.
  • Manage deviations and CAPAs.
  • Oversee Regulatory Intelligence and Change Control documentation.
  • Develop GxP training content and support audits / inspections.
  • Guide site quality teams in process implementation.

Required Qualifications :

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • 2 years of experience in Quality Systems in biotech / pharma.
  • Process ownership and quality systems management experience.
  • Technical writing, SOPs
  • Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines.
  • Experience with electronic quality management systems (Veeva).
  • Preferred Qualifications :

  • Master's degree in a related field.
  • ASQ certification (CQA, CQM).
  • Lean Six Sigma experience.
  • International work experience.
  • Change management and organizational development experience.
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