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.
• Worker is required to clear a vision test including acuity & color blindness prior to starting the assignment.

Education:

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