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Inspection & Packaging Supervisor, 3rd Shift
INCOG BioPharmaUnited Statesfull_timeVerifiedPosted 10 Feb 2025
About the role
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. 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. This is a 3rd shift position. Essential Job Functions:
- Provide technical support and leadership in the implementation of visual inspection program.
- Train inspection operators 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.
- Lead the team of qualified inspectors and manage manufacturing activities.
- BS in Engineering/ Science or applicable military service
- Previous leadership experience, with a preference of previous supervisory experience.
- 8 years related experience in the development or support of processes, quality inspection, or pharmaceutical packaging.
- Must pass health and visual checks and annual eye inspections.
- Knowledge of Aseptic techniques and processing.
- Strong understanding of Visual Inspection and Packaging requirements.
- 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.
- Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques, and process capability.
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