Manufacturing Specialist
Hayward, CA
Schedule:
1st Shift (6am - 2:30pm)
Duration:
5-Month Contract
Pay Rate Range:$26/ph - $32/ph
Join a leading biotechnology manufacturer providing critical support to production teams. This role focuses on ensuring product quality, optimizing processes, and maintaining compliance with established quality systems.
Key Responsibilities:
- Analyze production data to identify trends and implement improvements in efficiency, quality, and cost.
- Investigate process discrepancies in collaboration with Process Engineering and Lifecycle Management (LCM) teams.
- Support validation efforts by contributing to validation plans, protocols, and execution.
- Serve as a subject matter expert (SME) for MES and eDHR systems during development and change initiatives.
- Create and revise quality documents, including work instructions, pFMEAs, test reports, and batch records.
- Participate in continuous improvement initiatives using Lean Six Sigma and Operational Excellence methods.
- Assist with internal audits, corrective actions, and audit responses.
- Test sequencing instrumentation using approved procedures.
- Troubleshoot non-conforming products in collaboration with Manufacturing, Quality, and LCM teams.
- Maintain records of instrument failures and defects.
- Perform other related duties as required.
Education & Experience:
Required: - High school diploma or GED
- Some college-level STEM coursework or technical training preferred
Preferred: - Bachelor’s degree in Engineering, Chemistry, Biology, or Physics
- 0–2 years of relevant technical experience
- Experience with DNA sequencing instrumentation or similar diagnostic equipment
Knowledge & Skills: - Ability to follow detailed work instructions and operate in a regulated manufacturing environment
- Excellent troubleshooting, documentation, and communication skills
- Strong organizational skills and attention to detail
- Ability to collaborate across multifunctional teams
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Familiarity with quality systems, SOPs, DHRs, GLP, GMP, SAP, and ECO processes is a plus
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