This candidate will be responsible for overseeing all activities of the teams responsi ble for cleaning and sanitizing the manufacturing facility, cleaning of primary, secondary, and ancillary equipment, and assembly of production related manufacturing tanks, vessels, and supply assemblies in support of the manufacture of Commercial and Clinical Biologics. Th is individual will be accountable for the Safety, Quality, Deliver, Cost , and Engagement metric s associated with the Production Support department and ensuring that all work performed in the department are following standard cGMP documented practices per the assigned shift . This individual will be responsible for following Current Good Manufacturing Practices ( cGMPs ). A day in the Life: Able to complete all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. Documentation of all activities to meet cGMP requirements. Daily logbook review, tasks, and databases. Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling conflicts with one week outlook. Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. Represent manufacturing team at tier meetings. Practices and promotes safe work habits and adheres to safety procedures and guidelines. Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations. Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures. Maintain safe and clean work environment by educating and directing personnel to ensure compliance with established policies and procedures. Coordinates training with team either in class or on the floor, as needed. Helps build cross-functional relationships and enhances relationships with team members. Provides frequent feedback and coaching to others on ways to improve performance. Complete production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results. Lead shift exchanges and daily huddles for team as . Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees