This is a 3rd shift position (Sunday Thursday) 8:45PM to 7:15AM (50 hours per week)
Shift coordination of Manufacturing activities. Maintain a technical understanding sufficient to provide front-line instruction for production issues.
Assume responsibility for the GMP, environmental health and safety procedure awareness, and compliance within the respective area. Support OpEx initiatives, efficiency, and continuous improvement.
Personnel Supervision. Supervise personnel in support of Compounding and Aseptic Prep activities in the pursuit of daily excellence.
Assign work to manufacturing personnel. Coordinate the daily workflow with Group Leaders from other shifts.
Production Scheduling. Work directly with the Planning Department in development of the production schedule.
Identify equipment and personnel requirements and provide solutions for constraints. Coordinate shift activities and facilitate the transfer of activities between shifts. Communicate with internal customers as frequently as required. Coordinate and escalate equipment issues with appropriate technical resources.
Personnel Training and Development. Oversees technical training of personnel.
Mentors new personnel in behaviors and job expectations. Engages in the identification of training plan based on business needs. Reports progress to the Team Leader.
Participates in development of training plan. Ensures SOP's are read; provides technical SOP training.
Compliance. Understands and enforces daily area compliance in safety/EHS procedures, GMP, and SOP/batch record adherence.
Audits area compliance. Evaluates quality performance with the Team Leader and/or Manufacturing Quality Assurance.
Operator Substitution. Perform manufacturing compounding and/or aseptic prep operator functions when necessary.
Projects: Participate on project teams and R&D projects.
Coordinate new product Process Validation and Cleaning Validation activities. Attend GMP training sessions as scheduled. Represent Manager in project meetings.
Serve as leader of Operational Excellence Projects. Support OpEx and WISE OWLS initiatives.
Documentation. Review area documentation including batch records and logbooks as necessary.
HS Diploma; practical knowledge of engineering, chemistry or physics.