Manufacturing Associate – 2nd Shift | Fremont, CA | 4-Month Contract
Job Title: Manufacturing Associate – 2nd Shift
Job ID: 37554422
Location: Fremont, CA
Job Type: Contract – 4 Months
Work Arrangement: 100% Onsite
Shift: 2nd Shift, Monday–Friday, 2:00 PM–10:30 PM
Job Overview
Sigma Inc. is seeking a Manufacturing Associate for a 4-month onsite contract opportunity with our client in Fremont, CA. This is an excellent opportunity for candidates with GMP, pharmaceutical, biotechnology, manufacturing, assembly, or packaging experience who are looking to build their career in a regulated manufacturing environment.
The Manufacturing Associate will perform routine manufacturing assembly and packaging operations for drug products in a multi-product facility. The position works under limited supervision while following SOPs, batch records, cGMP requirements, safety procedures, and controlled documentation practices.
Key Responsibilities
- Perform routine assembly and packaging operations in a GMP-regulated manufacturing environment.
- Assist Senior and Master Associates with manufacturing activities.
- Assist with setup of automated autoinjector assembly machines, pre-filled syringe assembly machines, and semi-automated tabletop equipment.
- Gather required tools, machine parts, documents, components, and equipment.
- Retrieve materials and components from designated storage areas.
- Assist with equipment changeovers, minor repairs, and adjustments.
- Help identify and resolve mechanical and component-related issues during production.
- Document manufacturing activities accurately in batch records, logbooks, SOP attachments, and other controlled documents.
- Record production events and promptly escalate issues to the Production Supervisor.
- Verify equipment calibration status and complete equipment logbooks as required.
- Perform assembly, packaging, visual inspection, and filling activities as assigned.
- Ensure components, materials, and supplies are available before production begins.
- Move products, components, and equipment within designated manufacturing areas.
- Maintain production rooms according to established 5S standards.
- Assist with room cleaning, equipment removal, sanitization, and waste disposal.
- Transfer waste to designated transfer zones according to safety procedures.
- Follow controlled documents and established SOPs for all manufacturing activities.
- Communicate effectively and complete appropriate shift handoffs.
- Follow all company safety policies, SOPs, cGMP requirements, and documentation practices.
- Identify unsafe conditions and escalate concerns appropriately.
Required Qualifications
- High school diploma or GED required.
- Minimum 1 year of work experience in a GMP-regulated industry with a high school diploma/GED.
- Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments is strongly preferred.
- Associate or bachelor's degree from an accredited institution or biotechnology vocational training is preferred.
- Ability to read, understand, and follow detailed written instructions and SOPs.
- Strong attention to detail and organizational skills.
- Basic mathematical skills, including addition, subtraction, multiplication, division, and unit conversions.
- Strong written and verbal communication skills.
- Ability to work effectively in a team environment.
- Basic computer skills, including Microsoft Office, Outlook, and other manufacturing software.
- Ability to work in a fast-paced manufacturing environment while maintaining accuracy and compliance.
- Ability to stand and walk for extended periods and perform routine manufacturing activities.
Ideal Candidate Background
Candidates with experience in the following areas are encouraged to apply:
- GMP Manufacturing
- cGMP
- Pharmaceutical Manufacturing
- Biotechnology Manufacturing
- Drug Product Manufacturing
- Medical Device Manufacturing
- Assembly & Packaging
- Production Associate
- Manufacturing Associate
- Manufacturing Technician
- Equipment Changeover
- Batch Records
- SOPs
- Controlled Documentation
- Visual Inspection
- Filling Operations
- Autoinjector or Syringe Assembly
- 5S / Lean Manufacturing
- Cleanroom or regulated production environments