Quality Control Associate I, Bioassay

US-CA-Seal Beach
Job ID
2017-1062
Category
Quality Control

Overview

Dendreon is looking for a Quality Control Associate I with 2+ years related experience in cGMP/FDA regulated industry. This person will be responsible for performing daily lab operations with the assigned functional area related to the release of product, and/or monitoring of the IMF environment, as well as complete other assigned duties.

 

The QC Associate I uses professional concepts and company policies and procedures to solve a variety of problems, works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors, and exercises judgment within defined procedures and practices to determine appropriate action. This person normally receives general instructions on routine work, detailed instructions on new assignments.

Responsibilities

  • Bioassay: assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods include flow cytometry, ELISA, endotoxin, complete blood count, viability, and gram stain.
  • 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 and exception reports for out-of-limit samples, and of 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. 
  • Interacts with and partners with other associates within the department.
  • Supports department and site leadership.
  • Reports to respective shift Supervisor.

Qualifications

  • Associate's or Bachelor’s (preferred) degree in a scientific discipline or equivalent. 
  • 2+ years related experience in cGMP/FDA regulated industry.
  • Knowledge of basic lab testing techniques.
  • Basic level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. 
  • 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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