Aseptic Lead

Role Summary

Leverage scientific expertise to execute the MEC monitoring program and conduct testing in a GMP environment. Ensure the generation of high-quality data from the MEC program to support accurate data interpretation and assess compliance with internal standards and regulatory requirements. Provide training to laboratory personnel on established techniques and methodologies, and prioritize and complete assigned tasks to meet organizational objectives and deadlines.

Responsibilities

• Learn and become proficient with the use of Thermo SampleManager 21 Laboratory Information Management (LIMS) system.
• Perform visual assessment of colony growth recovered from monitoring and accurately enumerate the results into the LIMS system.
• Perform MEC testing per the established procedures without errors for routine and non-routine operations.
• Perform MEC testing during final bottling operations.
• Work with department leadership to participate in the continuous improvement strategy as it pertains to changes in SOP, documentation, reporting, and technological improvements.
• Drive completion of assignment task and project assigned such as trend report generation, review and approval on a quarterly basis.
• Operate as an extension of management to lead, organize, and provide guidance to analysts in the EM team.
• Independently troubleshoot and resolve EM technique and instrumental issues.
• Understand the EM techniques and instruments' performance in accordance with scientific principles.
• Develop a knowledge of the sample excursion workflows and what impact these events have on the facility. Escalation of the excursions and working with manufacturing to assess what action needs to be taken and can support any investigation related to contamination and environmental monitoring.
• Leading the EM team’s Tier meeting and effective communicating any escalations and action items.

Qualifications

• Bachelor’s degree with 5-7 years of laboratory experience; Associate degree with at least 8 years of experience
• Ability to work independently and effectively manages their own time to multi-task based on their complete training matrix.
• Participates and contributes to assigned teams to me broader business objectives.