Manufacturing Visual Inspector (2nd shift)

Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.

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• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
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• Executes independently with adequate training, complex fundamental operations as visual inspection, advance visual inspection, palletizing, cleaning, inspection hood prep for operations, BioMES Operations and Exceptions.
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• Performs internal support duties including assisting drug product filling and packaging.
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• Executes independently with adequate training fundamental operations:
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-Logistics Coordination

-Batch record executions

-Equipment use logs

-Work order initiation and tracking

-Support Projects

-Support Creation/Maintain Training Kits Documents work according to cGMP and cGDP.

-Adheres to established regulations and follows cGMP established by site.

-Reports abnormalities and deviations in a timely and accurate manner.

-Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.

-Maintains production areas according to predefined standards (5s).

-Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.

-Contributes to Quality activities such as supporting investigations, corrective actions and area walk throughs.

-1 or more years of experience in cGMP regulated industry.

-Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and "Right the first-time mindset.

-Strong written and verbal communication skills.

-Ability to work with computer-based systems and manufacturing execution systems (MES).

-Ability to read and understand SOPs and instructions and document work in a written format applying cGMP standards.

-Ability to work as part of a high performing team and collaborate effectively with staff.

-Must be able to read and see clearly.

PHYSICAL DEMANDS:

- Duties of this position may require the incumbent to exert some physical effort.

-Lifting requirements may vary dependent on the drug product manufacturing visual inspection area activity. Weight is typically no more than 25 pounds.

NOTE: Worker required to clear VISION TESTING (acuity & color blindness) before starting assignment.

Education:

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• High school degree + minimum 1 year work experience in GMP regulated industry
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• Associates/Bachelor's degree or biotechnology vocational training preferred
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Schedule Notes:2nd Shift: Mon-Fri, 2PM-10:30PM