Job Details

Manufacturing Associate I - Assembly & Packaging

  2025-12-12     Astrix     Fremont,CA  
Description:

Our client, a leading organization in the pharmaceutical and biotechnology manufacturing sector, is seeking a detail-oriented Manufacturing Assembly & Packaging Associate to support drug product production in a cGMP-regulated, multi-product facility. In this role, you will perform routine unit operations for assembly, packaging, and support troubleshooting efforts-all in strict compliance with standard operating procedures (SOPs).

Job Title: Manufacturing Assembly & Packaging Associate
Location: Fremont, CA
Terms: Contract-to-hire
Shift: 1st Shift | Monday-Friday, 6:00 AM-2:30 PM
Pay Rate: $22.15/hr

Responsibilities:

  • Assist in setting up automated and semi-automated equipment including autoinjector assembly, syringe assembly, and tabletop packaging systems.
  • Retrieve and prepare components, tools, and documentation prior to equipment setup.
  • Support equipment changeovers and minor equipment repairs or adjustments.
  • Identify and resolve operational issues during assembly and packaging processes.
  • Perform accurate documentation in controlled documents such as batch records, logbooks, and SOP attachments.
  • Execute assembly and packaging tasks and assist with visual inspection/filling operations as needed.
  • Ensure proper stocking of components, supplies, and materials before operations begin.
  • Transfer products and materials within the Controlled Non-Classified (CNC) manufacturing area.
  • Maintain cleanliness of production rooms, including waste disposal and sanitization in line with safety procedures.
  • Follow all safety protocols and report unsafe conditions immediately.
  • Participate in shift hand-off communications to ensure operational continuity.
  • Maintain 5S standards and ensure equipment used is properly calibrated and documented.
  • Complete required logbooks and maintain documentation compliance.

Qualifications:
  • High School Diploma or equivalent required; Associate or Bachelor's degree or biotechnology vocational training preferred.
  • Minimum 1 year of experience in a GMP-regulated manufacturing environment (pharmaceutical or biotechnology industry strongly preferred).
  • Basic computer skills (MS Office, Outlook, and other systems).
  • Strong organizational skills and ability to work in small teams.
  • Ability to read, comprehend, and follow written instructions.
  • Demonstrated math proficiency, including basic arithmetic and conversions.
  • Strong verbal and written communication skills.
  • Ability to stand for extended periods and perform physical tasks including lifting, bending, twisting, and climbing.
  • Must be fully vaccinated against COVID-19 or have an approved medical/religious exemption.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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