Postado em: Outros em Vermont | Última actualização: |
Job Description
Purpose
Responsible for the daily supervision and training of operating personnel in the production of clinical or commercial products. Works in concert with other supervisors. Responsible for the accurate and timely completion of production related cGMP documentation. Responsible for implementation of manufacturing procedures. Ensures the effective use of material, equipment, and personnel in producing quality products.
Responsibilities
Reviews daily production schedule and priorities to determine unit (suite) assignments and critical actions.
Reviews all materials and batch records required to support shift and any off-shift needs for the day.
Provides on the floor training to support formalized technical and cGMP training. Checks that operator training files match and support the processes they are required to carry out.
Monitors operator training files and works with compliance specialist to keep files up to date.
Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions.
Works with technology transfer team to incorporate new processes in the plant.
Reviews new Batch records and SOPs.
Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as adviser to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel.
Evaluates staff performance.