Environmental Monitoring Analyst I

Burlington, MA

The Microbiology Specialist performs microbiological activities in support of production. The role performs environmental monitoring of the clean rooms for microbial and particulate counts. The specialist will direct and coordinate personnel sampling and certification in clean room setting and will perform all non-routine sample collection in support of SOP or investigation requirements.

  • Essential Duties and ResponsibilitiesPerform environmental monitoring of the clean rooms (under USP and EU specifications) both viable and non-viable monitoring
  • Read, trend and report environmental, personnel, in-process, raw material, finished product and water testing results
  • Provide support of general QC Microbiology Laboratory activities such as:
  • Chart reading and changing
  • Equipment cleaning and maintenance
  • Maintaining supplies and inventory
  • General laboratory housekeeping
  • Daily preparation of paperwork, supplies, and equipment for EM testing in clean room setting
  • Perform microbial plating of personnel during manufacturing and personnel qualification
  • Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated
  • Resolve environmental equipment malfunctions or errors
  • Perform non-routine or infrequent sampling (e.g., semi-annual static particulate monitoring, quarterly compressed air monitoring)
  • Perform cGMP documentation, review sampling worksheets for documentation errors
  • Facilitate the revision and release of all controlled documents
  • Facilitate mandatory reviews of SOPs
  • Maintain current training status on equipment, procedures, and test methods
  • Provide additional support to QC Microbiologists and complete tasks as needed

Supervisory ResponsibilitiesThis job has no supervisory responsibilities.

  • Education and/or Experience RequiredHigh School Diploma
  • Minimum 0-1 years’ relevant experience
  • PreferredAssociate’s degree in Science or related field
  • Previous experience with pharmaceutical cleanroom environments
  • Knowledge, Skills and AbilitiesComputer proficiency (Windows environment)
  • Attention to detail with executing established processes
  • Ability to write reports and correspondence
  • Ability to speak effectively before groups of customers or employees
  • Proficient and comfortable in business meetings and work related social and business development situations
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals and communicate this information to others
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  • Knowledge of Manufacturing, Spreadsheet and Word Processing software

Physical DemandsWhile performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work EnvironmentWhile performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

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