37339665 Manufacturing Visual Inspection Associate (2nd Shift) GMP / Pharma
Sigma, Inc.
Manufacturing Visual Inspection Associate (2nd Shift) GMP / Pharma
Fremont, CA (Onsite) 2nd Shift: 2:00 PM 10:30 PM (MondayFriday) Contract: 12 Months (Potential Extension) Company: Sigma Inc.
Job Overview
Sigma Inc. is hiring a Manufacturing Visual Inspection Associate to support pharmaceutical manufacturing operations in a cGMP-regulated environment. This role focuses on visual inspection of drug products, ensuring quality, compliance, and accuracy in a high-performance production setting.
If you have experience in GMP manufacturing, quality inspection, or biotech/pharma production, this is a great opportunity to grow your career.
Key Responsibilities
- Perform manual and advanced visual inspection of drug products
- Execute batch record documentation in compliance with cGMP and cGDP standards
- Support filling, packaging, and palletizing operations
- Prepare and maintain inspection hoods and production areas
- Track and document work orders, equipment logs, and MES entries
- Identify and report deviations, abnormalities, and quality issues
- Assist with logistics coordination and internal production support
- Maintain cleanroom standards (5S) and adhere to safety protocols
- Participate in quality investigations, CAPA activities, and audits
- Support training documentation and onboarding of new team members
Required Qualifications
- High School Diploma or GED required
- 1+ year experience in GMP/cGMP regulated environment (pharma, biotech, or medical device)
- Strong attention to detail and ability to perform visual inspection tasks
- Experience following SOPs and work instructions
- Ability to document work accurately using batch records and manufacturing systems (MES/BioMES)
- Good written and verbal communication skills
- Ability to work in a team-oriented, fast-paced manufacturing environment
Preferred Qualifications
- Associate's or Bachelor's degree in Biotechnology, Life Sciences, or related field
- Experience in:
- Visual inspection in pharma/biotech
- Cleanroom operations
- Packaging and filling operations
Physical & Work Requirements
- Ability to stand for extended periods
- Lift up to 25 lbs as needed
- Must pass vision testing (including color differentiation)
- Comfortable working in a controlled manufacturing/cleanroom environment
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