What are the responsibilities and job description for the Sterility Assurance Technician position at Exela Pharma Sciences?
Position Summary
The Sterility Assurance Technician is responsible for working to maintain the Contamination Control Strategy for Exela Pharma Sciences, LLC. This individual should be able to work with direction from Sterility Assurance Management to uphold the policies and procedures related to completion of media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations, and sterility failures. The individual is expected to coordinate project execution and to work alongside Sterility Assurance, Quality, and Operations personnel to ensure execution. The primary responsibility is to maintain sterility assurance of aseptically filled and terminally sterilized drug products.
Job Responsibilities
- Assist with implementation of continuous improvement initiatives within the Sterility Assurance Program
- Participate in the trending and implementation of any corrective actions or continuous improvement associated with the microbial control strategy for production processes from incoming raw materials through final product release
- Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill protocols and reports, validations and specifications.
- Draft and assist with execution of applicable documentation for the Media Fill Program
- Draft and assist with execution of applicable documentation for Cleanroom Qualification activities.
- Provide quality support for Airflow Visualization Studies
- Participate as needed with maintenance and development of the Aseptic training program
- Participate in root cause investigations into microbiological and manufacturing process nonconformances.
- Assist Sterility Assurance and Quality management during routine audits by regulatory agencies, pharma manufacturing partners and internal corporate auditors.
- Assist as a facility sterility assurance SME on product development and commercialization of new products
Experience Requirements
- Microbiology background, ideally within a sterile manufacturing site with more than one sterile production line.
- Two (2) or more years relevant work experience in cGMP related industry and/or Pharmaceutical Microbiologically.
- Experience with validation of sterile processes would be advantageous.
Education Requirements
- Bachelor's degree in science, engineering, or other related technical field.
