This is a contractor to hire position at a fast moving biotech company. NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. POSITION SUMMARY The EM Technician position works closely with other departments, such as Operations, Validations, Maintenance, Quality Systems, Product Release and Engineering to assure the support of the Environmental Monitoring department on various projects, studies and routine tasks. The individual holding the position of EM Technician shall be responsible for the timely completion of routine and project testing. This person will also be responsible assisting in actions associated with environmental issues. KEY RESPONSIBILITIES Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP?s, FDA, OSHA and other regulatory agencies. Responsible for routine environmental monitoring samples in the classified areas. Performs environmental monitoring and the collection of utility samples. Assists in the investigation of Environmental Excursions. Assists in preparing and executing protocols for performance qualifications and re-qualifications. Evaluation and monitoring of personnel for Aseptic Behavior. Compiles data for quality metrics. Development and revision of standard operating procedures. Assists in training new department personnel and personnel of different departments on SOPs relative to Environmental Monitoring. Performs evaluation of the classified areas with regards to fit and finish. Assists with the execution of equipment and method validation. Assists in compiling data for Annual Reports. Identify opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Obtain and maintain high level gown certification. Assumes additional duties and responsibilities as assigned. REQUIREMENTS Associated or undergraduate degree or equivalent and minimum 2-4 years comparable experience within the biotech/pharmaceutical industry; or Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP?s, FDA, OSHA and other regulatory agencies. Experience with GMP biotechnology or pharmaceutical companies Read, comprehend and execute Standard Operating Procedures (SOP) and instruction documents.
Associated topics: agriculture, agrosciences, air, air monitoring, climate, environmental, epa, farm, field, sustainable