Manufacturing Visual Inspection

JobDiva, Inc.; Fremont (CA); On-site; USD 42,000 - 65,000; Full time

Job summary

JobDiva, Inc. in Fremont, CA seeks a detail-oriented technician for routine unit operations in visual inspection within a multi-product drug manufacturing facility. You will follow cGMP procedures, assist with filling/packaging, and maintain accurate logs and training records.

Ideal candidates have 1+ year GMP experience, strong written and verbal communication, and the ability to work with MES and SOPs. The role requires lifting up to 25 pounds and adherence to safety standards on a 1st shift

Qualifications

• High school degree + minimum 1 year work experience in GMP regulated industry.
• Associates or Bachelor's degree or biotechnology vocational training preferred.
• Ability to read and understand SOPs and instructions and document work in writing per cGMP standards.

Responsibilities

• Executes routine unit operations in Visual Inspection related to drug product manufacturing.
• Performs duties under limited supervision per SOPs and manufacturing procedures.
• Executes independently with adequate training for visual inspection, palletizing, cleaning, hood prep, and MES operations.
• Supports drug product filling, packaging, and internal logistics tasks.
• Maintains logs for work orders, equipment usage, and batch records.
• Contributes to quality activities including investigations and corrective actions.
• Maintains safety standards and site 5S cleanliness.

Skills

cGMP experience

Detail-oriented

Written and verbal communication

MES experience

SOP literacy

Education

High school + 1 year GMP

Associates or Bachelors in biotech

Tools

MES

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 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 a Vision Test (including acuity & color blindness) prior to starting assignment.

Education:

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


• Associates/Bachelor's degree or biotechnology vocational training preferred

Schedule Notes:1st Shift: Mon-Fri, 6AM-2:30PM

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