Manufacturing Visual Inspection

eTeam; Fremont (CA); On-site; USD 34,000 - 48,000; Full time

Job summary

eTeam is seeking a Manufacturing Visual Inspection professional in Fremont, CA for a 12-month contract. The role involves routine unit operations in visual inspection for drug product manufacturing in a multi-product facility, under cGMP procedures.

Responsibilities include assisting filling/packaging, batch records, logistics, and training others post-qualification, while adhering to safety and 5S standards and complying with SOPs and regulatory expectations.

Qualifications

• 1+ year of experience in a cGMP regulated industry.
• Detail-oriented work in a complex technical setting with quality focus.
• Strong written and verbal communication skills.
• Ability to read SOPs and document work per cGMP standards.

Responsibilities

• Perform routine unit operations in Visual Inspection per SOPs.
• Assist drug product filling and packaging.
• Logistics coordination and batch record execution.
• Operate MES and other computer-based systems.
• Maintain production areas per 5S and safety standards.
• Report deviations and safety issues promptly.
• Train others after trainer qualification.

Skills

Detail-oriented

Strong written and verbal comm.

Team collaboration

Safety awareness

SOP comprehension

Education

High school diploma

Associates/Bachelor's preferred

Tools

MES (Manufacturing Execution Systems)

Job description

Job Title

Manufacturing Visual Inspection

Location

Fremont, CA

Duration

12 Months

Shift

Mon-Fri, 2PM-10:30PM (10% Shift differential applied on 1st day of work)

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.

NOTE

Worker required to clear VISION TESTING (acuity & color blindness) before starting assignment.

Education

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

Associates/Bachelor's degree or biotechnology vocational training preferred