Quality Assurance Associate (#156)

  • Full-time
  • Department: Quality Assurance

Company Description

We develop and manufacture fully functioning human cells in industrial quantities to precise specifications. Our proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products).

Our iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics.

Job Description

Cellular Dynamics is currently hiring a Quality Assurance Associate at our Novato, CA facility, located within the Buck Institute. This position will assure compliance to the quality system through audits and inspections.

Skills and Job Responsibilities:

  1. Review finished product batch records
  2. Review Quality Control data in an electronic LIMS system
  3. Review and approve final product vial labels for accuracy and compliance
  4. Perform internal audits of facilities and systems for compliance to standard operating procedures
  5. Audit data for compliance to internal procedures and protocols
  6. Write and/or review SOPs. 
  7. Write deviations.
  8. Other duties as assigned.



Qualifications

Job Requirements:

  • A.S./B.S. in Biology or related field and a minimum of 1-2 years of QA experience, preferably in a GMP facility.
  • Ability to work independently with minimal supervision.
  • Must be detail oriented with excellent organizational skills.
  • Demonstrate the ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, potentially changing, priorities.
  • Experience using Thermo Nautilus LIMS software preferred.
  • Strong technical writing skills with a good command of grammar and punctuation.
  • Expertise using Microsoft Office products. 
  • Experience with Microsoft SharePoint is a plus.


Additional Information

Cellular Dynamics International Inc. is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability.  All qualified applicants will not be discriminated against on the basis of a disability.