We are seeking a dedicated and detail-oriented Operations Test Associate to join our team. The ideal candidate will have a Bachelor’s degree in a science-related field and 1 to 2 years of industrial lab experience, preferably in Quality Control (QC). The candidate must be familiar with GMP/GLP practices and possess intermediate computer skills, particularly with Microsoft programs. Knowledge of ERP, LIMS, and/or QSR systems is preferred.

Key Responsibilities

• Environmental Monitoring (EM): Perform Bioburden testing, Growth Promotion, and Bacterial and Fungal Identifications.
• Routine Testing: Execute routine tests in compliance with GMP/GLP standards.
• Data Analysis: Analyze and interpret results, comparing them to protocol-defined specifications, validity criteria, and alert limits.
• Inventory Management: Maintain product and QC material inventories.
• Lab Maintenance: Ensure the cleanliness and organization of the laboratory, including stocking shelves and drawers with testing materials.
• Equipment Maintenance: Maintain and clean laboratory equipment, calibrating or arranging calibration as needed.
• Training Compliance: Complete required training promptly and maintain training records.
• Laboratory Investigations: Participate in investigations for invalid assays and out-of-specification results.
• Documentation Management: Prepare documents for storage in the document management system and manage original data files.

• Education: Bachelor’s degree in a science-related field.
• Experience: 1 to 2 years of industrial lab experience, preferably in Quality Control (QC).
• Computer Skills: Intermediate proficiency in Microsoft programs.
• Industry Knowledge: Working knowledge of industry/regulatory standards and GMP/GLP requirements.
• Preferred Skills: Familiarity with Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and/or Quality System Regulations (QSR).

Additional Information

The Operations Test Associate may be required to perform additional duties as needed by business requirements. This is an onsite position with a start date as soon as possible. The shift is expected to be 40 hours per week, with a flexible start time between 7am-9am, ending around 3:30pm-5:30pm.