Role:

The Operations Test Associate candidate will be responsible for performing QC release testing and analysis of raw material, in-process, and finished goods. 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.

• May perform microbiology testing and activities for the QC Micro team.

• 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