• Quality Analyst I - Bioassay

    Job Locations US-GA-Union City
    Job ID
    2018-1323
    Category
    Quality Control
  • Overview

    The  Quality Analyst I, Bioassay 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.

    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

    Scope: 

     

    • 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. Exercises judgment within defined procedures and practices to determine appropriate action.
    • Normally receives general instructions on routine work, detailed instructions on new assignments.

     

    Qualifications

    • High School Diploma or Equivalent Required
    • Associate or Bachelor’s (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

     

     

     

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