• 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.

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 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