Manufacturing Visual Inspection

• Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• 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.
• Performs internal support duties including assisting drug product filling and packaging.
• Executes independently with adequate training fundamental operations:
• -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.

• - 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 a Vision Test (including acuity & color blindness) prior to starting assignment.

• High school degree + minimum 1 year work experience in GMP regulated industry
• Associates/Bachelor's degree or biotechnology vocational training preferred

Schedule Notes:1st Shift: Mon-Fri, 6AM-2:30PM

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