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
Job Summary
Provide technical and process support to the manufacturing team to achieve production plans while maintaining quality and compliance with company 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 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.
Required Education
- High school diploma or GED.
Preferred Education
- Relevant college-level STEM coursework or training.
- Bachelor’s degree in Engineering, Chemistry, Biology, or Physics.
Experience and Skills
- 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.
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