Manufacturing Specialist

Title:

Manufacturing Specialist

Location:

Hayward, CA — Onsite
Pay: $27.00-$31.00/hr

Schedule:

Monday–Friday, 8:00 a.m.–4:30 p.m.
Duration: 6-month contract

Provide technical and process support to the manufacturing team to achieve production plans while maintaining quality and compliance with company quality systems.

• Analyze production data to identify trends and define actions to improve efficiency, product quality, and cost.
• Identify process discrepancies and collaborate with Life Cycle Management and Process Engineering on improvements.
• Support maintenance of the validated state by providing subject matter expertise on validation plans and verification and validation protocols, and executing released protocols.
• Act as a subject matter expert during development and change management for Manufacturing Execution Systems (MES) and electronic Device History Record (eDHR) processes and systems, collaborating with IT, Process Engineering, and Quality.
• Support the development, creation, and modification of quality documents, including work instructions, procedures, process failure mode and effects analyses (pFMEAs), validation test reports, batch record templates, and test methods.
• Participate in continuous improvement teams and projects using Operational Excellence and Lean Six Sigma methodologies.
• Participate in the manufacturing internal audit program and assist with corrective actions and audit responses.
• Test next-generation DNA sequencing instrumentation using released procedures and processes.
• Troubleshoot products and process nonconformances in collaboration with Manufacturing, Quality, and Life Cycle Management.
• Establish and maintain reports of instrument failures and defects.
• Perform other duties as needed.

• High school diploma or GED.

• Relevant college-level STEM coursework or training.
• Bachelor’s degree in Engineering, Chemistry, Biology, or Physics.

• No previous technical experience is typically required; detailed instructions are normally provided for all work.
• Strong organizational skills, attention to detail, and accuracy.
• Ability to work independently within a team environment.
• Ability to collaborate with cross-functional teams and manage ambiguity.
• Strong interpersonal, verbal, and written communication skills.
• Excellent troubleshooting skills.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP ERP systems is a plus.
• Hands-on experience with clinical or diagnostic instrumentation, including DNA sequencing instrumentation or equivalent, is highly desirable.