Describe the primary goals, objectives or functions or outputs of this position.
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.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
•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. .
•Five plus years’ experience in all aspects of manufacturing/ production processes •Experience in leading manufacturing and production teams in some capacity, such as shift or team lead or any previous supervisory experience. •Familiarity with industrial automation (e.g., distributed control and PLC-based systems) •Working knowledge of safety, quality systems, and cGMPs is required •Computer proficiency and scheduling experience required; good writing skills required. .