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 interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communication at all levels.

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