POSITION OVERVIEW

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

PHYSICAL REQUIREMENTS

• Be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
• Exposure to chemicals used in during assay preparation (special safety precautions must be taken when working with these chemicals)
• Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned
• Must be able to wear required PPE for long periods of time when required

RESPONSIBILITIES

• Conduct analytical testing per Standard Operating Procedures (SOPs) and regulatory requirements including potency, material identification, particulate and dissolution.
• Maintain daily use, maintenance and cleaning logs for 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.
• Participate in test method and equipment validations.
• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Assists the Laboratory Manager as needed.
  SUPERVISE DIRECT REPORTS (yes or no)