Job ID: 37744970
Company: Sigma Inc.
Location: Fremont, CA
Duration: 6-Month Contract
Work Arrangement: Onsite
Shift: 1st Shift, Monday–Friday, 6:00 AM–2:30 PM
Sigma Inc. is seeking a detail-oriented Manufacturing Visual Inspection Technician to support pharmaceutical drug product manufacturing at a multi-product facility in Fremont, California.
The ideal candidate will have experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment, with a strong focus on visual inspection, quality, documentation, and compliance. This position involves inspecting drug products, performing manufacturing operations, maintaining accurate batch records, and supporting production activities in accordance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP).
Candidates who are quality-focused, comfortable working with computer-based manufacturing systems, and committed to getting the job done right the first time are encouraged to apply.
Shift: 1st Shift
Days: Monday–Friday
Hours: 6:00 AM–2:30 PM
Location: Fremont, California
Duration: 6-month contract
Work Arrangement: Onsite
Perform routine manufacturing operations related to visual inspection of pharmaceutical drug products in a multi-product facility.
Conduct visual inspection and advanced visual inspection activities following established procedures and training requirements.
Perform palletizing, cleaning, inspection hood preparation, and other manufacturing support operations.
Execute BioMES operations and document exceptions as required.
Provide internal support for drug product filling and packaging operations.
Coordinate logistics and support manufacturing material movement as needed.
Complete batch records, equipment use logs, work orders, and associated production documentation accurately.
Initiate and track work orders and support manufacturing improvement projects.
Assist with the creation and maintenance of training documents and training kits.
Follow cGMP, cGDP, standard operating procedures (SOPs), and site-specific manufacturing requirements.
Identify and report abnormalities, deviations, and quality concerns promptly.
Maintain production areas in accordance with established 5S standards and workplace safety requirements.
Maintain required training compliance and assist in training other technicians after obtaining trainer qualification.
Support quality activities, including investigations, corrective actions, and area walkthroughs.
Work collaboratively with manufacturing, quality, and other cross-functional teams to maintain production standards.
High school diploma or equivalent.
At least 1 year of experience in a cGMP-regulated industry.
Experience or familiarity with pharmaceutical or biotechnology manufacturing operations is preferred.
Strong attention to detail and the ability to perform repetitive, detail-oriented inspection tasks.
Ability to read, understand, and follow SOPs, work instructions, and manufacturing procedures.
Ability to complete accurate written documentation in compliance with cGMP and cGDP requirements.
Familiarity with computer-based systems and manufacturing execution systems (MES).
Strong written and verbal communication skills.
Ability to work effectively in a team-oriented manufacturing environment.
Commitment to quality, safety, compliance, and right-first-time execution.
Ability to read clearly and perform visual inspection tasks requiring sustained concentration.
Associate or bachelor's degree in biotechnology, life sciences, or a related field.
Biotechnology vocational training.
Previous experience in pharmaceutical manufacturing, drug product inspection, filling, or packaging.
Experience with batch record execution, BioMES, manufacturing documentation, and equipment logs.
Familiarity with 5S, deviation reporting, quality investigations, and corrective actions.
Ability to perform manufacturing duties that may require physical effort.
Ability to lift up to approximately 25 pounds, depending on the assigned manufacturing activity.
Successful completion of a vision test is required before the assignment begins. Testing includes visual acuity and color blindness assessment, with acceptable results required for placement.
| Location | Fremont, CA |
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