Job Description

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 such as visual inspection, advanced 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/maintenance of 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 or 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 walkthroughs.

Required:

• High school diploma and a minimum of 1 year of work experience in a GMP-regulated industry
• Associate’s or Bachelor’s degree, or biotechnology vocational training, preferred.
• 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 depending on the drug product manufacturing visual inspection area activity. Weight is typically no more than 25 pounds.
• Required to participate in and have acceptable results from vision testing, including color blindness.

Shift: 6:00 am - 2:30 pm M-F

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