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Quality Control Analyst II - Microbiology

Company: Organogenesis
Location: Canton
Posted on: September 15, 2018

Job Description:

Quality Control Analyst II - Microbiology



in Canton, MA

The QC Analyst I/II - Microbiology performs quality activities in support of product production and releases. The QC Analyst I/II communicates with internal departments at Organogenesis and with outside contacts including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing and reporting results. This individual works in a Microbiology environment.

Job Responsibilities include but are not limited to:

  • Media preparation.
  • Maintain laboratory cleanliness
  • Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration
  • Orders and maintains inventory of supplies.
  • Perform raw material, intermediate, and cell bank testing
  • Perform visual inspection of finished product.
  • Prepares and send out samples for testing for cell banking.
  • Assists in cross-functional activities to support release of final product (e.g. final product inspection, environmental/clean utility monitoring, endotoxin/biological testing and donor tissue ship/receipt)
  • Performs tasks in accordance with SOPs and regulations (cGMP and GLP)
  • Complies with company health and safety regulations and procedures.
  • Performs other duties as assigned.

    Job RequirementsJob Requirements

    • A BS degree in microbiology, biology or a related scientific discipline, or equivalent, is required.
    • 2-3 years of related experience in a cGMP/GLP regulated environment is required.

      Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition of employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards.

      This position requires a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K. This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires use of repetitive hand movement e.g. micropipetting and keyboard use for moderate or long periods of time



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      Keywords: Organogenesis, Boston , Quality Control Analyst II - Microbiology, Professions , Canton, Massachusetts

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