Sterility Assurance Manager

1 week ago

Houston, Texas, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science & Clinical is currently seeking a Sterility Assurance Manager for one of our clients, a biopharma/biotech company in near Southwest Houston.

As a Sterility Assurance Manager you will be responsible for all areas related to environmental monitoring, aseptic processing and microbial control at our clients Houston GMP manufacturing facility. This individual will lead the effort in establishing and overseeing the environmental monitoring and aseptic processing programs to collect baseline data and set acceptance criteria for initial performance qualification. This role will also be responsible for maintaining the qualification status of operator training, aseptic filling processes and integrity testing.

Essential Responsibilities

  • Establish environmental sampling maps for defined clean room areas
  • Scheduling and participating in daily, weekly and monthly monitoring of the cleanroom environment
  • Manage and training staff on operation of the MODA Environmental Monitoring (EM) data collection system
  • Baseline sampling and initial performance qualification of the GMP manufacturing facility EM sampling of GMP Cleanroom suite during at-rest and in-operation activities
  • Scheduling of Water system and clean steam sampling and testing
  • Prepare and approve trending and technical reports
  • Establishing alert and action limits based on statistical analysis of environmental data at rest and in operation
  • Investigating and recommending corrective actions for environmental excursions
  • Training and developing QC support staff in microbiological techniques and procedures
  • Training and qualifying Manufacturing staff in aseptic techniques
  • Maintaining aseptic process validation and operator qualification programs
  • Support Manufacturing during aseptic processing simulation activities
  • Support batch and raw material testing including growth promotion, bioburden, and endotoxin testing.
  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
  • Other activities as defined by the Director of Quality Control

Education/Skills Required

  • BA or BS degree, Masters degree or higher in Microbiology, Biology or related science field
  • A minimum of 5 years related experience in a GMP environment is required
  • Previous supervisory experience preferred
  • Experience using electronic systems (MODA EM) for data collection and technical report writing
  • Working knowledge of current Good Manufacturing Practices (cGMP) related to Biologics manufacturing
  • Good aseptic techniques
  • Understanding of clean room HVAC operation
  • In depth understanding of microbiology and statistics
  • Knowledge of USP and EP endotoxin, bioburden and sterility requirements
  • Knowledge of Microsoft Office products
  • Time management skills required for organization of daily and weekly monitoring schedule
  • Record keeping skills required to ensure accuracy and authenticity of data
  • Organizational skills required for maintaining proper sample management

Job Details

  • Direct hire
  • M-F, day shift
  • Salary DOE + Full benefits

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