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Sterility Assurance Microbiologist

2 months ago

Boulder, Colorado, United States RBW Consulting Full time

Sterility Assurance Microbiologist

RBW Consulting is collaborating with a reputable pharmaceutical organization renowned for its extensive experience in the industry. We are in search of a knowledgeable Sterility Assurance Microbiologist to enhance our Sterility Assurance Program.

This position offers a unique opportunity for autonomy and promotes a culture of experimentation in developing effective procedures. If you are eager to be part of a dynamic company with ambitious growth objectives for both your career and the organization, this role may be an excellent fit.

Key Responsibilities:

  1. Assess proposed manufacturing methods and their controls to identify potential risks of microbial, endotoxin, and particulate contamination.
  2. Provide specialized knowledge across all sterility assurance initiatives, including disinfectant evaluations, assessments of resident microflora, airflow pattern analysis, and environmental monitoring.
  3. Engage in both internal and external audits to ensure adherence to regulatory standards.
  4. Utilize quality enhancement tools and methodologies to address nonconformities, deviations, and obstacles to improvement.
  5. Contribute to initiatives aimed at boosting quality performance.
  6. Draft, review, and authorize technical documentation pertinent to sterility assurance.
  7. Risk Assessment: Lead or assist in conducting risk assessments related to sterility assurance.
  8. Root Cause Analysis: Investigate and resolve challenges associated with sterility assurance.
  9. Compliance Oversight: Ensure compliance with environmental monitoring, aseptic process simulations, and other sterility assurance protocols on the production floor.
  10. Procedure Development: Author and maintain quality system procedures, policies, and documentation.
  11. Industry Compliance: Review procedures to ensure alignment with industry standards.

If you are passionate about enhancing sterility assurance practices, we invite you to join us in our mission to foster a safer and cleaner environment.