Quality Control Associate II, Bioassay

Job Locations US-CA-Seal Beach
Job ID
Quality Control


The Quality Control Associate II, Bioassay individual is Responsible for performing daily lab operations within the assigned functional area related to the release of product, and/or monitoring of environment, in addition to other tasks related to the overall productivity and operation of the department.


  • Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods may include flow cytometry, ELISA, endotoxin, complete blood count, viability, gram stain and cell culture.
  • Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures.
  • Initiates and takes ownership as needed of laboratory investigations for invalid assays and non-conformance and exception reports for out-of-specification test results, as well as perform impact assessment and root cause investigation.
  • Participate in and initiates other projects and related assignments
  • Performs routine laboratory equipment maintenance.
  • Revises and updates standard operating procedures.
  • Performs testing in support of method validation studies.
  • Adheres to good documentation practices to ensure data integrity and traceability.
  • Performs stability tests including cell culture and immunoassay methods
  • Participate in and initiate other projects and related assignments
  • Assists with training of QC personnel
  • Able to organize and provide analytical data with some supervision upon request
  • Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Normally receives no instructions on routine work, general instructions on new assignments.


  • Associate or Bachelor’s (preferred) degree in a scientific discipline or equivalent.
  • Typically 5+ years related experience in cGMP/FDA regulated industry.
  • Strong knowledge of basic lab testing techniques.
  • Intermediate level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
  • Attention to detail, quality and compliance with strict adherence to test procedures and protocols
  • Ability to learn new technologies and processes quickly and to understand the technical concepts behind each assay performed.
  • Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
  • Proficient in MS Office applications.


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