Key responsibilities:
- Employee will be expected to participate in all aspects of department visual inspection program, including preparation of the inspection suite, stocking of related supplies, performance of inspection of injectable products, completion of associated logbooks and batch documentation, and storage of finished product.
- Individual can pass color-blindness and vision testing (must achieve 20/20 with or without vision correction such as glasses or contact lenses).
- Must be able to pass visual appearance testing method competencies within 90 days of hire.
- When not inspecting, employee will be asked to complete training in and perform functions in manufacturing operations, which may include vial washing, component rinsing and preparation, Container Closure Integrity testing, and other manufacturing tasks as requested.
- Employee will also assist with department consumables storage and stocking programs.
- Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
- All job functions will be performed according to procedure and in accordance with cGMP, Standard Operating Procedures, and safety codes and regulations. Identifies risks to business for consideration by management.
- Assist and contribute to GMP and safety self-inspection activities.
- Accountable for delivering innovation in the Clinical Supply Chain to deliver cost savings, reduce risk and improve service.
- Accountable for reporting and maintaining metrics as appropriate.
- Zero instances of data falsification or data integrity issues by staff.
- Employee has basic computer skills including Word, Outlook, and ability to navigate simple website interfaces.
- Education and Experience:
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Knowledge, Skills and Abilities:
Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations,