QC Lab Technician

Position Overview

The Operations Test Associate will perform QC release testing and analysis of raw materials, in-process, and finished goods for the Molecular Diagnostics Division. The candidate is responsible for executing testing on multiple assay platforms in a cGMP environment to ensure the timely release of products.

Key Responsibilities

• Perform routine testing using GMP/GLP practices.
• Analyze data and interpret results comparing to protocol-defined specifications, validity criteria, and alert limits.
• Perform microbiology testing and activities for the QC Micro team, and pH and/or HPLC testing for the QC Analytical team, as required.
• Maintain product and QC material inventories.
• Ensure laboratory and equipment cleanliness; stock testing materials and manage equipment calibration.
• Complete training in a timely manner and maintain training records.
• Participate in laboratory investigations for invalid assays and out-of-specification results.
• Prepare documents for storage in the document management system and manage original data files.
• Perform additional function-related activities as reasonably required by business needs.

Required Qualifications

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

Preferred Qualifications

• Working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR.