Quality Assurance Associate

Job description

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

The Quality Assurance Associate 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.

Duties and responsibilities may be added, deleted, or changed at any time at the discretion of management, formally or informally, in either verbal or written form.

Essential duties and responsibilities:

  • Assist with maintenance of established quality management system
  • Perform internal or Supplier audits and ensure compliance
  • Review, release, track and monitor nonconforming material reports, document change control, complaints and CAPA
  • Ensure facility and equipment are properly sterilized, maintained, calibrated, and validated
  • Perform periodic audits of production facility
  • Participate in risk assessments and design control
  • Customer complaint handling

 

  • Requires an understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485
  • Experience: A minimum of 3 years of experience in either the medical device or pharmaceutical/biotech industry
  • Education: Bachelor’s degree in a biological or chemistry discipline. Other educational experience will be considered in conjunction with work experience
  • Strong oral and written communication skills
  • Proven ability to work in a team environment
  • Strong multitasking capabilities and ability to prioritize
  • Prior IVD experience is highly desirable
  • Proven ability to identify and implement improvements in manufacturing and quality processes that are efficient, sustainable and compliant
  • Experience in working with international business environment or with overseas manufacturing site a plus
  • Experience in Regulatory Affairs or product registration desirable

  • Accepted file types: pdf, doc, docx.
  • Moving to new facility at Poway soon.
Position Summary

Essential duties and responsibilities:

  • Assist with maintenance of established quality management system
  • Perform internal or Supplier audits and ensure compliance
  • Review, release, track and monitor nonconforming material reports, document change control, complaints and CAPA
  • Ensure facility and equipment are properly sterilized, maintained, calibrated, and validated
  • Perform periodic audits of production facility
  • Participate in risk assessments and design control
  • Customer complaint handling

 

Education/Experience
  • Requires an understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485
  • Experience: A minimum of 3 years of experience in either the medical device or pharmaceutical/biotech industry
  • Education: Bachelor’s degree in a biological or chemistry discipline. Other educational experience will be considered in conjunction with work experience
  • Strong oral and written communication skills
  • Proven ability to work in a team environment
  • Strong multitasking capabilities and ability to prioritize
Skills and Abilities
  • Prior IVD experience is highly desirable
  • Proven ability to identify and implement improvements in manufacturing and quality processes that are efficient, sustainable and compliant
  • Experience in working with international business environment or with overseas manufacturing site a plus
  • Experience in Regulatory Affairs or product registration desirable
Apply Now

  • Accepted file types: pdf, doc, docx.
  • Moving to new facility at Poway soon.

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