QC Environmental Monitoring Associate

3 weeks ago

Exton, United States Beacon Hill Full time

General Responsibilities:

  • Performs environmental monitoring in support of aseptic product manufacturing.

Responsibilities:

  • Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring inside the clean rooms
  • Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
  • Perform Growth Promotion testing on prepared media
  • Direct Sterile Media Fill Trials and perform support testing
  • Maintain housekeeping in the Quality Control laboratories
  • Assist the Quality Control department in daily operations, as needed
  • Author and revise QC SOPs as necessary to maintain compliance
  • Timely response to Out of Specification (OOS) results, including notification to area supervision
  • Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
  • Employment of myriad analytical equipment in support of product quality
  • Training of other employees as necessary
  • Completion of thorough Manufacturing Investigation Reports (MIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented

Computer Skills

  • To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

  • Minimum Bachelor of Science degree in a scientific discipline

Experience:

  • Knowledge of Current Good Manufacturing Practice and Industry standards
  • Experience in a similar role in the biologics or pharmaceutical industry
  • Experience in aseptic processing and mammalian cell culture production
  • Familiarity of basic laboratory equipment such as microscopes, pH meters, incubators
  • Excellent verbal, written and organizational skills
  • Good interpersonal and communication skills
  • Must be open to occasional off shift and weekend work

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