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

• High School Diploma or GED.
• Some college-level STEM coursework or related technical training preferred.

Preferred Background & Skills

• Bachelor's degree in Engineering, Chemistry, Biology, Physics, or related field preferred.
• No prior technical experience required; detailed instructions will be provided.
• Strong organizational skills and attention to detail.
• Ability to work both independently and collaboratively in a team environment.
• Strong communication and troubleshooting skills.
• Proficient with Microsoft Office (Excel, Word, PowerPoint).
• Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP is a plus.
• Hands-on experience with diagnostic or sequencing instrumentation is highly desirable.

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