We are currently seeking two temporary Operations Test Associates to be part of the dynamic Operations Testing and Support Team. The analysts will learn how to perform testing on several platforms for various product lines. Duties and Responsibilities Maintain test schedule in a dynamic manufacturing environment using GMP/GLP practices. 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. Execute product date extension testing, provide quality and value add edits to QC documents, understand and utilize root cause analysis tools, generate sound retest designs for invalid and out of specification results, participate on method validations/assay qualifications, identify and implement continuous improvement ideas, execute test protocols and lab investigations. Qualifications: Working knowledge of Enterprise Resource Planning (ERP), LIMS, QSR, GMP/GLP requirements. Working knowledge of industry/regulatory standards; Intermediate computer skills; Education BA or BS degree in scientific discipline; Experience 1 year + of paid laboratory experience in a corporate setting, preferably Operations or QC. Additional Details: Sit; use hands to finger, handle or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Lifting/moving and carrying products weighing up to 40 pounds. Exposure to moving mechanical parts, vibration and/or moderate noise levels. Exposure to hazardous chemicals or other materials. Must follow all applicable FDA regulations and ISO requirements. 

Preferred background/prior work experience? Bachelor's degree in scientific field; at least one-year paid work in a scientific/molecular laboratory; pipette experience a plus; GLP, GDP, & GMP knowledge a plus; aseptic technique, manual dexterity.

Priority soft skills: Effective verbal and digital communication, professional work etiquette, increase breadth of personal training to support product availability, demonstrates strong peer to peer communication, calm under pressure, team oriented, detail oriented, productive, honest.

BG Required