Aseptic Area Team Leader, MD Fill, 2nd Shift

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Job description

Job Description

Purpose

Responsible for the daily supervision and training of operating personnel in the production of clinical or commercial products. Responsible for the accurate and timely completion of production related cGMP documentation. Ensures the effective use of material, equipment, and personnel in producing quality products.

Responsibilities

Leads the team inside the Multi Dose Filling clean rooms throughout the assigned shift.

Serves as an aseptic mentor, including, but not limited to the following:Train personnel in Aseptic Techniques and processes.

Complete daily inspections of the physical conditions of the aseptic area.

Communicate openly to operators and supervisors in aseptic core principles to provide mentoring regarding observed performance.

Oversees all tasks on the floor as they are carried out and provides assistance and troubleshooting where needed.

Communicates end of shift status to the next shift supervisor and to the unit manager as required for smooth hand off on a daily basis. Uses the shift log approach to manage the days goals and responsibilities in line with the priorities.

Reviews, on a shift wide-basis, the batch records for error and deviations, signing off responsibility to the next supervisor after this review.

Provides daily guidance primarily to nonexempt employees. Coordinates activities of sub-group and actively works with other sub-groups. Evaluates staff performance.

Partner with Quality to ensure compliance when issues arise.

Assist in cleaning, setup, and operation of the Filling equipment per critical business needs.

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