Manufacturing Visual Inspection 1st shift

About the role

Executes routine unit operations in Visual Inspection 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 such 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.

Responsibilities

• Executes independently with adequate training fundamental operations: logistics coordination, batch record executions, equipment use logs, work order initiation and tracking, and support projects.
• 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, escalating 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.

Requirements

• 1 or more years of experience in a 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 may require exerting some physical effort.
• Lifting requirements vary but typically do not exceed 25 pounds.
• Worker required to clear a Vision Test (including acuity & color blindness) prior to starting assignment.

Qualifications

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