Sr. QA Specialist

Employer
Synthego
Location
94063, Redwood City
Posted
Apr 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

Synthego is searching for a Quality Assurance Specialist to join our team and help create the world’s first fully automated cloud-enabled lab.

A perfect candidate would thrive in a fast paced, dynamic environment. S/he will have a player-coach mentality with the ability to adapt to changing requirements and priorities. Possessing the ability to partner with cross-functional leaders to exact change and drive continuous improvement is a must.

What You'll Do

  • Assist with implementation and management of various quality systems including but not limited to change control and document control
  • Process documents and records for various quality systems in accordance with documented procedures
  • Create and monitor corrective and preventative actions to eliminate and prevent causes of nonconformance
  • Creates and manages workflows within electronic QMS/PLM systems
  • Supports maintenance and distribution of controlled documentation
  • Identifies gaps, recommends process improvements, and proposes changes
  • Supports internal and regulatory audits/inspections as required
  • Manages training and compliance program
  • Participates in continuous improvement activities and projects
  • Participates in authoring or revising Standard Operating Procedures (SOPs) to ensure compliance and quality objectives are met
  • Maintains document templates and formats. Performs general word processing tasks
  • Reviews and archives manufacturing, quality control, and reagent/raw material data
  • Participates in Material Review Board meetings and product dispositions as applicable

About You

  • 5+ years relevant experience in a life science company with increasing levels of responsibility
  • Minimum of Bachelor’s Degree in a scientific discipline or equivalent experience
  • Possess working knowledge of cGMP and/or ISO13485 systems
  • Possess working knowledge of quality management systems (QMS), processes, and procedures
  • Familiarity with problem solving, root cause analysis tools, impact assessment, and CAPAs
  • Experience with QMS software platforms. Experience with Arena Solutions PLM is a plus
  • High degree of attention to detail
  • Strong documentation skills
  • Responsible and accountable with non-compromising high ethical standards