Manufacturing Visual Inspection

LanceSoft • Fremont, CA

1d

About The Position

Executes routine unit operations in Visual Inspection related to drug product manufacturing in a multi-product facility. Works under limited supervision and follows standard operating and manufacturing procedures. After adequate training, independently performs complex fundamental operations, including visual inspection, advanced visual inspection, palletizing, cleaning, inspection hood preparation, and BioMES operations and exceptions. Provides internal support to drug product filling and packaging.

Also performs logistics coordination, batch record execution, equipment-use logging, work-order initiation and tracking, project support, and creation and maintenance of training kits. Documents work in accordance with cGMP and cGDP, follows site regulations and procedures, promptly reports abnormalities and deviations, and adheres to safety standards. Maintains production areas to established 5S standards and keeps personal training current. After trainer qualification, trains other technicians and associates. Contributes to quality activities, including investigations, corrective actions, and area walkthroughs.

The schedule is Monday through Friday, 2:00 PM–10:30 PM. The worker must pass visual acuity and color-blindness testing before starting the assignment. Physical effort may be required, with lifting typically no more than 25 pounds; requirements may vary by activity.

Requirements

• At least 1 year of experience in a cGMP-regulated industry.
• High school degree and at least 1 year of work experience in a GMP-regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical environment with a quality-focused, right-first-time mindset.
• Strong written and verbal communication skills.
• Ability to use computer-based systems and manufacturing execution systems (MES).
• Ability to read and understand SOPs and instructions and document work in writing according to 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.
• Must pass vision testing for visual acuity and color blindness before starting the assignment.

Nice To Haves

• Associate or bachelor’s degree, or biotechnology vocational training.

Responsibilities

• Perform routine visual-inspection unit operations in a multi-product drug manufacturing facility.
• Independently perform, after adequate training, visual inspection, advanced visual inspection, palletizing, cleaning, inspection hood preparation, and BioMES operations and exceptions.
• Assist drug product filling and packaging operations.
• Perform logistics coordination, batch record execution, equipment-use logging, work-order initiation and tracking, project support, and training-kit creation and maintenance.
• Document work according to cGMP and cGDP and follow applicable site regulations and procedures.
• Report abnormalities and deviations accurately and promptly.
• Follow safety standards, identify unsafe situations or habits, and escalate them appropriately.
• Maintain production areas according to established 5S standards.
• Maintain personal training compliance and, after trainer qualification, train other technicians and associates on operations.
• Support quality activities, including investigations, corrective actions, and area walkthroughs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED