Aseptic Quality Coach

St. Louis, Missouri
Industry: Business Analyst / Project Manager
Job Number: JN -072021-66442

Role Summary:

  • The purpose of this role is to observe Aseptic Processing Areas while partnering with Aseptic Operations to continuously improve aseptic behaviors and techniques in the execution of production related activities. In the process of observing the behaviors, this individual will provide feedback to aseptic personnel and aseptic management. Additionally, observers/coaches will collect and evaluate information gained through the oversight process and interactively provide advice and direction toward improving manufacturing processes

 Role Responsibilities:

  • Continuously observe and review aseptic practices on the manufacturing floor as applicable to each Manufacturing suite.
  • Provide immediate feedback to Aseptic Coaches during routine observation to develop colleague capabilities.
  • Observe and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impact aseptic processing.
  • Observe aseptic process performance to support efficient and effective process operations.
  • Evaluate aseptic processes during validation smoke studies.
  • Observe aseptic technique during validation media fill simulations.
  • Maintain proper documentation – Training records, batch records, check sheets, logbooks.
  • Active member of investigational activities as it relates to environmental events.
  • Aseptic Qualifications are completed and maintained.
  • Must be self-motivated, able to work independently and have a problem-solving mindset.

Qualifications:

  • Education: Bachelor’s Degree in Science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)


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