1st Shift Manufacturing Visual Inspection

Sigma Systems, Inc.; Fremont (CA); On-site; USD 34,000 - 44,000; Full time

Job summary

Sigma Inc is seeking a Manufacturing Visual Inspection technician for the 1st shift in Fremont, CA, on a 6-month contract. The role requires on-site work in a GMP-regulated biopharma environment and involves routine visual inspection of drug products and related manufacturing tasks.

You will follow cGMP/SOPs, maintain production logs, and support quality investigations as needed. A high school degree and 1+ year in GMP are required; on-site work and vision test compliance apply.

Qualifications

• Must have a high school degree and at least 1 year in GMP-regulated industry.
• Associates or bachelor’s degree or biotechnology training preferred.
• Ability to read SOPs and work instructions and document work per cGMP.

Responsibilities

• Execute routine unit operations in Visual Inspection for drug product manufacturing.
• Follow SOPs and cGMP with supervision and accuracy.
• Perform visual inspection, palletizing, cleaning, hood prep, and related tasks.
• Maintain logs: batch records, equipment use, work orders; support projects.
• Adhere to safety, 5S, and raise deviations promptly.
• Train and assist others after trainer qualification.

Skills

Detail oriented

Communication

MES experience

SOP reading

Team collaboration

Education

High school degree

Associates/bachelors or biotech training

Tools

MES (Manufacturing Execution Systems)

Job description

37883822 1st Shift Manufacturing Visual Inspection, Fremont, CA, 6 Months Contract

Sigma Inc is currently looking for a Manufacturing Visual Inspection to work onsite in Fremont, CA

Schedule

1st Shift: Mon-Fri, 6.00 AM-02:30 PM

Responsibilities

• 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 Exeptions. 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.

Requirements

• High school degree + minimum 1 year work experience in GMP regulated industry;
• Associates/bachelors degree or biotechnology vocational training preferred.
• 1 or more year 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 work intructions 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. Employees requires to participate and have acceptable result from vision testing including color blindness.
• Duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of 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.