As a member of the Quality function, provides real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing. Partners with Site colleagues to create an environment of the highest performance standards of Aseptic operations. Drives continuous improvement in Aseptic Operations on site. This role requires shift work.
Responsibilities specific to Aseptic Manufacturing (in addition to other duties as assigned):
Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
Ensures Aseptic operations are carried out as per Site Procedures.
Continuously observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up.
Drives all aspects of Aseptic Performance of the shift team through observation and feedback.
Drives all aspects of Aseptic performance during sampling and testing.
Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team.
Completes real-time review of Batch Record documentation.
Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms.
Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions.
Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures.
Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing.
Drives a high-performance Aseptic culture across the site.
Actively leads and supports investigations.
Reviews and Audits Batch Records real-time
Reviews and Audits Manufacturing and Testing logs as required.
Completion of Line Clearance activities
Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas.
Provides key input to the development and maintenance of the Site Contamination Control Strategy.
Provides key input to the assessment of EM data and trends.