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. Facilitates the transfer, planning, implementation, and maintenance of manufacturing processes and procedures. Ensures the effective use of material, equipment, and personnel in producing quality products.

Responsibilities

Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit 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 GMP training. Check that operator training files match and support the processes they are required to carry out.

Monitors operator training files and work with compliance specialist to keep files up to date.

Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs.

Works with technology transfer team to incorporate new processes in the plant.

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

Ensures that direct materials budgets and overtime budgets are met.

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.

Ensures compliance with all applicable local, state, and federal regulatory requirements which include but are not limited to: OSHA's Process Safety Management (PSM) standard (29 CFR 1910.119) and EPA's Risk Management Planning (RMP) rule (40 CFR 68), Mechanical Integrity programs, PCI, DOT, EPA etc.

Creates a safety culture by setting direction to reduce or eliminate operations-related injuries or accidents, damage/loss of product or equipment, and unnecessary costs by ensuring that all equipment and facilities are maintained consistent with the safety, security, hygiene and standards set by AbbVie.