What are the responsibilities and job description for the Lead, Sterility Assurance position at Exela Pharma Sciences?
Position Summary
The Sterility Assurance Lead is responsible for working collaboratively with Sterility Assurance Trainers, as well as other department personnel at Exela Pharma Sciences, LLC to ensure good aseptic practices are maintained within the manufacturing areas. This individual should be able to work with direction from Sterility Assurance Management to uphold the policies and procedures for performance, scheduling, and review of aseptic manufacturing cleanroom training and assessments.
This individual should be able to direct and assist the Sterility Assurance Training staff with direction from Sterility Assurance Management to uphold the policies and procedures related to completion of aseptic gowning training and certification, performance and review of routine cleanroom and gowning assessments, and performance of root cause investigation activities in response to excursion level events. Additionally, the Sterility Assurance lead will collaborate with the training department to provide training tools to manufacturing personnel to proactively eliminate potential behaviors that can contribute to excursion level events. The primary responsibility is to coordinate and assist routine activities to ensure that the aseptic manufacturing areas maintain a state of control and that site contamination control strategies are enforced.
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 ensuring control of the aseptic manufacturing areas.
- Provide aseptic behavior expertise for Sterility Assurance Trainers and all personnel that enter the aseptic manufacturing areas.
- Schedule and assist with execution of routine training and assessment activities for the manufacturing areas.
- Assist with root cause investigations associated with excursion level events. Assist with implementation of training materials and corrective actions to prevent adverse trends.
- Drive the maintenance and process improvements associated with the Aseptic training program.
- Own and enforce site specific contamination control strategies.
- Assist Sterility Assurance and Quality management during routine audits by regulatory agencies, pharma manufacturing partners and internal corporate auditors.
Experience Requirements
- Microbiology/Aseptic Training background, ideally within a sterile manufacturing site with more than one sterile production line.
- Four (4) or more years relevant work experience in cGMP related industry and/or Aseptic Pharmaceutical Manufacturing.
- Experience with leadership in aseptic manufacturing would be advantageous.
Education Requirements
- Bachelor's degree in science, engineering, or another related technical field. Relevant industry experience can serve in place of formal education.
