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Quality Control Operator - Environmental Monitoring

Company: Abeona Therapeutics Inc.
Location: Cleveland
Posted on: June 13, 2021

Job Description:

The Quality Control Operator - Environmental Monitoring is a key part of our growing QC Team and will have primary responsibility for environmental monitoring, sampling and analysis in support of clinical and commercial product manufacturing. This individual will perform internal facility environmental assessments to confirm the facility is under control and within specifications. This person will coordinate all growth promotion and identity testing whether performed in house or by a third party.

Essential Duties and Responsibilities:

* Primarily responsible for work related to environmental control including facility sampling, reading plates, growth promotion, and environmental assessments as well as management, tracking, and organization of raw materials. * Collects samples in a classified clean environment (viable and non-viable particulate, viable surface, etc) * Operates appropriate sampling equipment to collect samples * Performs testing and records results in accordance with SOPs and Protocols * Prepares supplies required for testing and collecting samples * Provides input to improving QC systems and procedures to improve GMP. * Complies with company documentation practices (GDP). * Supports laboratory investigations related to test failures, discrepancies and deviations. * Coordinates raw material sampling, inspection, and release as required. * Coordinates sample results received from external laboratories. * Assists in everyday organization of laboratory including cleaning, maintenance and ordering of supplies * Performs other duties as assigned

Qualifications:

* High school diploma required. Basic laboratory experience is preferred. * Ability to work in a clean room environment, excellent organization skills along with good written and verbal communication skills. * Ability to work weekends and off-shift hours as needed to support manufacturing activities * Basic computer proficiency required * Must be able to perform sterile gowning as required in Production and QC Laboratory areas * Knowledge of GMPs, GLPs safety, proper documentation, and data integrity is preferred

#06022021

Keywords: Abeona Therapeutics Inc., Cleveland , Quality Control Operator - Environmental Monitoring, Other , Cleveland, Ohio

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