QC Assistant

Department: Quality Assurance

Reports to: QA Assistant Manager

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. Reasonable accommodations are available for qualified individuals with disabilities, upon request.

Simplifying diagnostics and Improving global health. Located in San Diego (Poway), CTK Biotech develops and manufactures innovative medical diagnostic tests for both clinical and research applications. Our IVD products allow medical professionals to meet patient needs by quickly and accurately diagnosing illness.  The simplicity and portability of our test kits makes them suited for use in a wide range of settings including remote and underresourced settings.

At CTK, the product marketing manager works at the intersection of product, sales, and marketing and works in parallel with project and product managers.

Summary: The QC Assistant is responsible for inspecting and reporting on material processes and products; performing and documenting visual, dimensional and functional inspection of in-coming raw material, intermediate material and finished product; responsible for some QA related work for maintaining and improving the quality management system.

Essential Duties and Responsibilities

Include the following:

  • Inspect incoming materials, in-process product, and finished product including reagent, ELISA, and PCR according to the product specification by visual inspection and lab testing
  • Review batch records or notebooks for product release
  • Review packing list and other documentation to approve shipment of product as required
  • Open deviation and track until its completion
  • Open and report non-conformity products and track until its completion
  • Generate and maintain product quality control records and COA
  • Interacts with Managers, and production staff for quality inspection requirements.
  • Conduct product stability study and generate report as needed
  • Conduct investigation into customer complaint, NCR, CAR and other product related issues as needed
  • Perform data analysis and generate reports for management review and quarter review
  • Conduct other testing and inspection as required per quality system
  • Undertake other projects related to quality system improvement as assigned
  • Assist with equipment calibration or monitoring as needed

Other duties as may be assigned

Education and/or Experience

BS or AA in biological science or equivalent experience.  IVD/Reagent experience preferred.

Required Knowledge, Skills and Abilities

  • Experience in techniques including SDS-PAGE, Bradford Protein Assay and ELISA
  • Excellent communication and report writing skills. A good level of English both in verbal and written communication is a must
  • Excellent Microsoft office skills, experience in File maker a bonus
  • Analytic and detail oriented
  • Punctual and reliable

Preferred Knowledge, Skill and Experience

Other Skills and Abilities:

  • Ability to write routine reports and correspondence.
  • Excellent organization and attention to detail.
  • Scientific writing skill.
  • Ability to multi-task.

  • Accepted file types: pdf, doc, docx.
  • This position will be located at our new extended facility in Poway (near Costco), California.

  • Equal Opportunity Employer

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