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.

Qualifications

• 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.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.