Operations Test Associate

Description

Status: Onsite

Hours: This will be a first shift position that is expected to be the normal 40 hours/week. Associates are expected to start between 7 a.m. and 9 a.m., so the shift will end between 3:30 p.m. and 5:30 p.m.

Required Education:

• Bachelor’s degree in a science-related field

Key Requirements:

• 1 to 2 years of industrial lab experience (preferably QC).
• Intermediate computer skills (i.e., M.S programs).
• Working knowledge of industry/regulatory standards and GMP/GLP requirements.
• Preferred working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR.

Role:

• 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:

• The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned below 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.
• May perform pH and/or HPLC testing for the QC Analytical 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.