Manufacturing Visual Inspection

Duties:
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.

Skills:

-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:

• High school degree + minimum 1 year work experience in GMP regulated industry



• Associates/Bachelor's degree or biotechnology vocational training preferred

Schedule Notes:2nd Shift: Mon-Fri, 2:00pm - 10:30pm