Title: Manufacturing Specialist

Location: Hayward, CA

Pay:$29.00 - $36.00/hour

Schedule: Standard Office Hours

Duration: 6-Month Contract




Responsible for providing technical and process support to the manufacturing team to effectively achieve production plans while maintaining quality and compliance with applicable Quality Systems.

Key Responsibilities

• Analyze production data to identify trends and define actions to improve efficiency, product quality, and cost.
• Identify process discrepancies and collaborate with Lifecycle Management (LCM) and Process Engineering to implement improvements.
• Support maintenance of the validated state by serving as a Subject Matter Expert (SME) on validation plans, verification and validation protocols, and execution of released protocols.
• Act as SME during development and change management activities related to MES and eDHR processes and systems in collaboration with GIS, Process Engineering, and Quality.
• Support development and, in some cases, create or revise quality documents such as work instructions, procedures, pFMEAs, validation test reports, batch record templates, and test methods.
• Participate in continuous improvement initiatives using Operational Excellence and Lean Six Sigma methodologies.
• Participate in the internal manufacturing audit program and assist with corrective actions and audit responses.
• Test next-generation instrumentation using released procedures and processes.
• Troubleshoot and process product non-conformances in collaboration with Manufacturing, Quality, and Lifecycle Management.
• Establish and maintain reports of instrument failures and defects.
• Perform other duties as assigned.

Essential Functions

All listed tasks and responsibilities are considered essential functions of this position. Business conditions may require reasonable accommodation for additional duties and responsibilities.

Required Education

• High school diploma or GED.
• Relevant college-level STEM coursework or technical training is a plus.

Preferred Education

• Bachelor’s degree (BA/BS) in Engineering, Chemistry, Biology, Physics, or related field.

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