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Operation Test Associate
2 months ago
Summary
The Operations Test Associate candidate will be responsible for understanding and executing testing on multiple assay platforms in a cGMP environment to ensure timely release of products, Environmental Monitoring (EM), Bioburden testing, Growth Promotion, Bacterial and Fungal IDs. The candidate will be responsible for maintaining laboratory instruments, equipment and processes and supporting continuous improvement programs.
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.
- Responsible for training QC analysts on test methods.
Education
- BA or BS degree
Experience
- Minimum 1-3 years of laboratory experience, preferably QC
