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Clinical Production Supervisor
2 months ago
Company Overview
AbbVie is dedicated to discovering and delivering groundbreaking medicines and solutions that tackle significant health challenges today while addressing future medical needs. Our aim is to make a profound impact on individuals' lives across several critical therapeutic domains, including immunology, oncology, neuroscience, and eye care, along with our offerings in the Allergan Aesthetics portfolio. For further details about AbbVie, please visit our website.
Position Summary
The Clinical Production Supervisor is accountable for overseeing and mentoring operational staff in the manufacturing of clinical or commercial products. This role collaborates closely with fellow supervisors to ensure the precise and timely completion of production-related cGMP documentation. The supervisor plays a crucial role in the transfer, planning, implementation, and upkeep of manufacturing processes and protocols, ensuring optimal utilization of materials, equipment, and personnel to produce high-quality products.
Key Responsibilities
- Establishes weekly objectives and schedules, prioritizing tasks for the team.
- Reviews the weekly production agenda and priorities to allocate unit assignments and identify critical actions.
- Examines all materials and batch records necessary to support daily operations.
- Provides on-the-job training to facilitate formal technical and GMP training, ensuring operator training files are accurate and support required processes.
- Monitors operator training documentation and collaborates with compliance specialists to maintain up-to-date records.
- Engages with QA and Subject Matter Experts to address exceptions and reviews new batch records and SOPs.
- Collaborates with the technology transfer team to integrate new processes into the facility.
- Works across departments to resolve work orders, dispensing, preventative maintenance, QC, and documentation issues, enhancing communication at all levels.
- Ensures adherence to direct materials and overtime budgets.
- Supervises primarily skilled nonexempt and junior exempt employees, acting as an advisor and mentor for less experienced personnel.
- Evaluates staff performance and ensures compliance with all relevant local, state, and federal regulations.
- Fosters a safety culture aimed at minimizing operations-related injuries, product loss, and unnecessary costs by maintaining equipment and facilities in line with AbbVie’s safety and hygiene standards.
Qualifications
- Bachelor's degree or equivalent experience; a minimum of eight years in manufacturing or production processes.
- Proficient in computer applications and scheduling; strong writing skills are essential.
- Solid understanding of safety, quality systems, and cGMP regulations.
- Familiarity with industrial automation, including distributed control and PLC-based systems.
- Experience with equipment and facilities validation.
Additional Information
AbbVie is committed to integrity, innovation, and diversity. We uphold a policy of employing qualified individuals without discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.
