Manufacturing Specialist 1

Job Title: Manufacturing Specialist
Location: Hayward, CA (Onsite)
Pay Rate: $30.00 – $31.00/hr
Duration: 6 Months+
Shift: Monday-Friday, 8am-4:30pm

Job Summary

The Manufacturing Specialist I provides technical and process support to the manufacturing team to help achieve production goals while ensuring quality and compliance with established Quality Systems. This role supports continuous improvement, troubleshooting, and documentation within a regulated manufacturing environment.

Key Responsibilities

• Analyze production data to identify trends and recommend improvements in efficiency, quality, and cost
• Identify process discrepancies and collaborate with Process Engineering and Lifecycle Management (LCM) teams
• Support validation activities, including execution of protocols and maintaining validated systems
• Serve as a subject matter expert (SME) for MES and eDHR systems during development and change management
• Create and update quality documentation (SOPs, work instructions, pFMEAs, validation reports, batch records, test methods)
• Participate in continuous improvement initiatives using Lean and Operational Excellence methodologies
• Support internal audits and assist with corrective actions and audit responses
• Perform testing on next-generation DNA sequencing instrumentation following established procedures
• Troubleshoot non-conformances and collaborate cross-functionally to resolve product issues
• Track and report instrument failures and product defects
• Perform additional duties as assigned

Required:

• High school diploma or GED
• Strong attention to detail, organization, and ability to work independently and within a team
• Excellent troubleshooting and problem-solving skills
• Strong communication (verbal and written) and interpersonal skills
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)

Preferred:

• Bachelor’s degree in Engineering, Biology, Chemistry, Physics, or related STEM field
• Experience working with SOPs, DHRs, ECOs, GLP/GMP environments
• Familiarity with SAP or other ERP systems
• Experience with clinical or diagnostic instrumentation (DNA sequencing preferred)

Benefits:(employee contribution)
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan


We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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