Demo

Senior Quality Systems Specialist

Germer International - Pharmaceutical Recruiting
Fremont, CA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/20/2025

Our client is seeking a Quality Assurance Specialist who will be responsible for maintaining product quality and compliance by working closely with departments such as manufacturing, R&D, and regulatory affairs. This role involves reviewing documentation, leading audits, investigating deviations, overseeing project initiatives, managing document workflows, and offering back-up support for quality control functions.

Qualifications :

  • Bachelor's in life sciences preferred
  • 7 years of quality assurance experience
  • Expertise in conducting audits, inspections, and assessments
  • Proficient in quality tools (e.g., Document Control, CAPA, Deviations, Audit, SPC)
  • Strong understanding of GMP / ISO regulations and quality management systems
  • Experience in the life sciences, pharmaceuticals
  • Familiarity with eQMS, ERP systems, and other information systems

Key Responsibilities :

  • Oversee CAPAs and document control
  • Conduct internal audits and support external audits
  • Review and approve quality documentation (e.g., SOPs, specifications)
  • Ensure compliance with regulatory standards
  • Investigate deviations and implement corrective actions
  • Support the development and maintenance of quality systems
  • Provide training on quality procedures and best practices
  • Participate in risk assessments and quality improvement initiatives
  • Track corrective and preventive actions to ensure timely resolution
  • Support data analysis, reporting, and vendor audits
  • Maintain accurate quality documentation and ensure compliance
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