Quality Inspector

Title: Manufacturing Visual Inspection

Location: Fremont, CA 94555

Duration: 06 months

1st Shift /2nd Shift (6 Opening)

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.
• Employees required to participate and have acceptable result from vision testing including color blindness.

Education:

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

Associates/Bachelor’s degree or biotechnology vocational training preferred