Role and Responsibilities

This position is responsible for performing quality control laboratory testing on incoming, in-process and finished products and assisting in laboratory operations. The focus of the position is compliance with regulatory activities and company procedures as they relate to the laboratory department. This position reports to the Laboratory Manager and Director of Quality.

Responsibilities include:

• Conduct chemical and biological testing per Laboratory Operating Procedures (LOPs) and regulatory requirements including microbial sequencing, gram staining, endotoxin, and pH.
• Maintain daily use, maintenance and cleaning logs for general laboratory areas, equipment, and utensils.
• Complete routine preventative maintenance of laboratory equipment to ensure accuracy of results.
• Prepare Certificates of Analysis for Quality review.
• Perform data entry, trending, and record organization.
• Support in drafting and reviewing procedures, change controls, risk assessments, deviations and CAPA.
• Assist in quality duties by performing incubator temperature verification and incoming material inspection.
• Participate in test method and equipment validations.
• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Assists the Quality Laboratory Manager as needed