QC Support Analyst I

Job Description

Job Summary:

•  The Operations Test Associate candidate will be responsible for performing QC release testing and analysis of raw materials, in-process, and finished goods for the Molecular Diagnostics Division.
• 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:

• 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.

Requirements:

• Bachelor’s degree in a science-related field.
• 1 to 2 years of industrial lab experience (preferably QC).
• Intermediate computer skills (i.e., Microsoft programs).
• Working knowledge of industry/regulatory standards and GMP/GLP requirements.
• Working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR.