Inspection and Packaging Supervisor

INCOG BioPharma Services • Fishers, IN

76d

About The Position

INCOG BioPharma is seeking an individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. The primary purpose of this role is to provide strong compliance and Visual Inspection start-up process support as well as technical leadership in the creation and deployment of the visual inspection program within INCOG BioPharma Operations. The primary function of this role is to facilitate the implementation and use of visual inspection processes and systems. This role will be responsible for developing and leading the inspection team and ensuring industry standards and regulatory requirements are met. This role will also provide direction related to automated visual inspection and packaging related technologies.

Requirements

• BS or MS in Engineering or Science or 8 years related experience in the development or support of pharmaceutical inspection processes, quality systems or a closely related field.
• Must pass health and visual checks and eye inspections annually.

Nice To Haves

• Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Strong understanding of Visual Inspection and Packaging requirements.
• Knowledge of Aseptic techniques and processing.

Responsibilities

• Provide technical support and project leadership in the implementation of visual inspection program.
• Train inspection operations and develop their capabilities to ensure Visual Inspection program sustainability.
• Coordinate the development of visual inspection specifications that maintain product quality and compliance.
• Develop processes to maintain and control the visual inspection requirements and coordinate the development of process procedures.
• Serve as subject Matter Expert in visual inspection and packaging technologies and quality/compliance requirements.
• Assure compliance with cGMP requirements (current good manufacturing practices).
• Lead the team of qualified inspectors and manage manufacturing activities.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees