Job Details

Title: Manufacturing Specialist

Location: Hayward, CA

Pay: $27.00- $32.00/hour

Schedule: Standard Office Hours

Duration: 6-Month Contract

Thisrole provides technical and process support to the manufacturing team to help achieve production plans while maintaining quality and compliance with established Quality Management 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 Lifecycle Management and Process Engineering teams to implement improvements
• Support maintenance of validated processes by serving as a subject matter expert (SME) for validation plans, verification, and validation protocols
• Act as an SME during development and change management for MES and eDHR processes and systems, collaborating with IT, Process Engineering, and Quality teams
• Support the development, creation, and modification of quality documentation, including work instructions, procedures, pFMEAs, validation test reports, batch record templates, and test methods
• Participate proactively in continuous improvement initiatives using Operational Excellence and Lean Six Sigma methodologies
• Participate in internal manufacturing audits and support corrective actions and audit responses
• Test next-generation DNA sequencing instrumentation using released procedures and processes
• Troubleshoot product nonconformances in collaboration with Manufacturing, Quality, and Lifecycle Management teams
• Establish and maintain reports related to instrument failures and defects
• Perform additional duties as assigned

Must-Have Qualifications

• 0-2 years of manufacturing laboratory experience
• Demonstrated ability to follow established protocols to assist in the production of complex organic molecules and modified oligonucleotides
• Experience working with SOPs, travelers, ECOs, and GMP environments
• Demonstrated basic chemistry, math, and analytical skills
• Working knowledge of SAP or equivalent ERP systems
• Strong interpersonal, verbal, and written communication skills
• Proficiency with Microsoft Excel and Outlook
• High attention to detail and accuracy
• Working knowledge of MRP and ERP systems

Preferred Qualifications

• Experience with Lean Manufacturing tools and principles
• Familiarity with ISO 9001, ISO 13485, and FDA QSR manufacturing standards

Required Education

• High school diploma or GED
• Relevant college-level STEM coursework or technical training is a plus

Preferred Education

• Bachelor's degree (BA/BS) in Engineering, Chemistry, Biology, Physics, or a related field

Experience & Skills

• Typically requires little to no prior technical experience
• Ability to follow detailed instructions and standard procedures
• Strong organizational skills with exceptional attention to detail and accuracy
• Ability to work independently and collaboratively in a team environment
• Comfortable collaborating across multifunctional teams and managing ambiguity
• Excellent troubleshooting and problem-solving skills
• Proficiency with Microsoft Office tools (Excel, Word, 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 or equivalent technologies, is highly desirable