Job Information
PharmaForce, Inc. QC Environmental Monitoring Technician II in Hilliard, Ohio
Nature and Scope This position EMT-II is a senior member of the Environmental Monitoring Team. The Environmental Monitoring Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT-II will be able to perform and oversee all activities associated with the environmental monitoring process; including water collection, air, surface and personnel monitoring. These activities are performed in accordance with established operating procedures to provide data that relates to the state of environmental control within the clean and aseptic areas of the sterile manufacture plant. The EMT-II will be able to provide training in addition to routine monitoring to all junior Environmental Monitoring Technicians as needed. The EMT-II will ensure the proper maintenance and calibration of monitoring equipment is in place and will be the responsible person for review of environmental monitoring paperwork. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Plan daily workload to meet requirements. Schedules work for Environmental Monitoring Team required based on Supervisor and Lead recommendations. Must complete and maintain gowning certification to work in clean room (Hilliard) and also help gown train other employees. Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Communicate any discrepancies or deviations to group lead/supervisor or appropriate authority upon discovery. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, as well as health and safety requirements. Maintains compliance with all required SOP's. Ensures equipment and supply inventories are maintained and available for use in accordance with department needs. Qualified departmental trainer. Performs investigations into environmental excursions and deviations under the guidance of the Environmental Monitoring Supervisor. Ensures only approved sampling materials are utilized at all times. Ensures that personnel do not perform tasks for which they do not have accurate and approved training records. Ensures that only approved documentation and procedures are utilized at all times. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associate Degree in microbiology, biology or related scientific field preferred. Minimum 1 year experience in environmental monitoring or equivalent experience required, preferably in the pharmaceutical /Food /medical device or Beverage industry. Knowledge of aseptic technique. Must be able to maintain Class 100 Certification for EM support. Ability to perform basic mathematical calculations. Ability to work independently with minimal supervision. Able to train other junior EMTs Organization and attention to detail. Ability to take feedback constructively and function in a team oriented work environment. Working knowledge of MS-Office software and PC Skills required. Good work ethic and highly motivated. Good time management skills. Ability to work in a fast paced environment. Must be able to re