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Quality Assurance Technician/Specialist

CTK Biotech is an international diagnostic products company that develops, manufactures and distributes reagents, lateral flow rapid tests and ELISA kits.  We accomplish our goals through world-class research, manufacturing, quality, regulatory compliance, and marketing / sales.

The Quality Assurance Technician/Specialist is responsible for assisting with every aspect of the company’s quality system. This person may also interface with customers or regulatory agencies during onsite audits and for product vigilance issues.

  • Support compliance and maintenance activities of established quality management system
  • Assist with internal and/or Supplier audits to verify compliance
  • Collect, monitor, trend, and report data through performance charts on nonconforming material reports, audit findings, complaints, CAPA and other QA related data
  • Perform and/or assist with investigations and write reports relating to NCRs, CAPAs, Audit findings, and Complaints as necessary.
  • Significant contributor to identifying and driving continuous improvement throughout CTK
  • Requires an understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485
  • Experience: A minimum of five years of QA experience in either the medical device or pharmaceutical/biotech industry
  • Education: Bachelor’s degree in a biological or chemistry discipline preferred. Other educational experience will be considered in conjunction with work experience
  • Strong oral and written communication skills
  • Proven ability to work in a fast-paced team environment
  • Strong multitasking capabilities and ability to prioritize assignments
  • Prior IVD manufacturing/QA experience is highly desirable
  • Proven ability to identify and implement improvements in manufacturing and quality processes that are efficient, sustainable and compliant
  • Auditing certification and/or experience a plus
  • Good problem-solving skills
  • Strong experience with Microsoft Office, specifically:
    • Excel spreadsheets for data collection and creating trending charts
    • Word for writing/editing documents
    • PowerPoint for presentations
    • Visio for process flow diagrams

Please apply through Indeed.

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