Manufacturing Specialist 1

Job Description

Title : Manufacturing Specialist

Pay : $25.00-$31.00 / hour

Location : Hayward, CA (Onsite)

Duration : 6-Month Contract

Schedule : 1st Shift (8-hour days; flexible start between 6 : 00 AM - 8 : 00 AM)

Job Description

Position Summary :

This role provides technical and process support to the manufacturing team to ensure production goals are met while maintaining quality, efficiency, and compliance with established quality systems.

Key Responsibilities

• Analyze production data to identify trends and recommend actions that improve efficiency, product quality, and cost.
• Identify process gaps and collaborate with engineering teams to drive improvements.
• Support validation activities as a subject matter expert, including reviewing validation plans, executing protocols, and ensuring validated state is maintained.
• Serve as an SME for MES and eDHR systems; collaborate with cross-functional teams during development and change management.
• Create, update, and support Quality Documents such as SOPs, work instructions, pFMEAs, test methods, batch record templates, and validation reports.
• Participate in continuous improvement initiatives using Lean and Operational Excellence methodologies.
• Contribute to internal audit activities and assist with corrective actions and audit responses.
• Test next-generation instrumentation using approved procedures.
• Troubleshoot product non-conformances and work closely with Manufacturing, Quality, and Life Cycle Management to resolve issues.
• Maintain reports tracking instrument failures and defects.
• Perform other duties as assigned.

Required Education

Preferred Background & Skills