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Manufacturing Associate

Sigma Inc - Fremont, CA

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Job Description

Manufacturing Associate (GMP / Assembly & Packaging) – 1st Shift | Fremont, CA | 6-Month Contract Location: Fremont, CA (Onsite) Shift: Monday – Friday | 6:00 AM – 2:30 PM Duration: 6-Month Contract (Potential Extension) Company: Sigma Inc. Job Overview Sigma Inc. is seeking a motivated Manufacturing Associate to support assembly and packaging operations in a GMP-regulated biotech/pharmaceutical manufacturing environment. This role involves working with automated assembly equipment, pre-filled syringe systems, and autoinjector machines, ensuring production processes meet quality, safety, and compliance standards. This is an excellent opportunity for candidates looking to grow their career in biotech manufacturing, pharmaceutical production, and GMP operations. Key Responsibilities Assist in assembly and packaging of drug products in a multi-product facility Support setup and operation of: Autoinjector assembly machines Pre-filled syringe systems Semi-automated manufacturing equipment Perform equipment setup, changeovers, and minor troubleshooting Follow SOPs, batch records, and GMP documentation practices (GDP) Maintain accurate production records and logbooks Assist with visual inspection and filling operations (as needed) Ensure availability of materials, components, and supplies before production Maintain cleanliness and 5S standards in production areas Support equipment cleaning, room sanitization, and waste disposal Communicate effectively during shift handoffs and team coordination Identify and escalate safety or quality issues Required Qualifications High School Diploma or GED 1+ year of experience in a GMP-regulated environment (preferred biotech/pharma) Ability to: Read and follow Standard Operating Procedures (SOPs) Perform basic math calculations Maintain accurate documentation (GDP compliance) Basic computer skills (MS Office, Outlook, email communication) Strong attention to detail and organizational skills Ability to work effectively in a team environment Preferred Qualifications Experience in biotechnology or pharmaceutical manufacturing Familiarity with: GMP (Good Manufacturing Practices) Batch records and production documentation Assembly/packaging equipment and processes Associate or Bachelor’s degree in a scientific or technical field Physical & Work Environment Standing and walking for extended periods Working in a manufacturing production environment Exposure to moderate noise and controlled conditions Requires focus and attention to detail to avoid production errors

Created: 2026-04-02

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