Quality Analyst I, Micro

Dendreon Corporation

Quality Analyst I, Micro

Seal Beach, CA
Full Time
Paid
  • Responsibilities

    Quality Analyst I, Micro Job Locations US-CA-Seal Beach Job ID 2018-1448 Category Quality Control Overview Quality AnalystI, Micro is 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. Responsibilities Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing. 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, growth promotion, and sterility. 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 Qualifications Associate or Bachelors (preferred) degree in a scientific discipline or equivalent. Typically 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.

  • Industry
    Biotechnology