Manufacturing Specialist
Posted 3 days ago by 1749707636
Negotiable
Undetermined
Undetermined
Hayward, California
Summary: The Manufacturing Specialist role is focused on supporting production teams in a biotechnology manufacturing environment. The position emphasizes product quality, process optimization, and compliance with quality systems. The specialist will analyze production data, collaborate with engineering teams, and contribute to validation efforts. This is a 5-month contract position based in Hayward, CA, with a pay rate ranging from $26 to $32 per hour.
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.
Key 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.
Salary (Rate): £26 hourly
City: Hayward
Country: United States
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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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