Key Responsibilities Include :
- 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 advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel.
- Evaluates staff performance.
- Requires a Bachelor's degree or equivalent. • Five plus years' experience in all aspects of manufacturing/ production processes
- Computer proficiency and scheduling experience required; good writing skills required.
- Familiarity with industrial automation (e.g., distributed control and PLC-based systems)
- Working knowledge of safety, quality systems, and cGMPs is required