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Operations Test Associate
3 weeks ago
Overview
The Operations Test Associate candidate will be responsible for Environmental Monitoring (EM) Bioburden testing, Growth Promotion, Bacterial and Fungal IDs. The candidate will be responsible for understanding and executing testing on multiple assay platforms in a cGMP environment to ensure timely release of products.
Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
- Performs routine testing using GMP/GLP practices.
- Performs data analysis and results interpretations comparing to protocol defined specifications, validity criteria, and alert limits.
- Responsible for maintaining product and QC material inventories.
- Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials.
- Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed.
- Responsible for completing training in a timely manner and maintaining the records.
- Participates in Laboratory Investigations for Invalid assays and Out of Specifications results.
- Prepares documents for storage in our document management system and manages original data files.
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