Manufacturing Specialist

Title: Manufacturing Specialist

Pay: $27.00-$31.00/hour

Location: Hayward, CA

Schedule: Standard Office Hours

Duration: 6-Month Initial Contract

In this role, you will provide technical and process support to the manufacturing team to help achieve production goals while maintaining quality and regulatory compliance. Key responsibilities include:

• Analyzing production data to identify trends and implement improvements in efficiency, product quality, and cost.
• Identifying process discrepancies and collaborating with cross-functional teams to drive improvements.
• Supporting validation activities, including execution of validation protocols and maintaining validated systems.
• Acting as a subject matter expert (SME) for manufacturing systems (e.g., MES, eDHR) during development and change management.
• Supporting and developing quality documentation such as work instructions, procedures, risk assessments (pFMEA), validation reports, and test methods.
• Participating in continuous improvement initiatives using Lean and Six Sigma methodologies.
• Assisting with internal audits, corrective actions, and audit responses.
• Testing and evaluating next-generation instrumentation using established procedures.
• Troubleshooting non-conformances and collaborating with Manufacturing, Quality, and Lifecycle teams to resolve issues.
• Maintaining reports related to instrument failures and defects.
• Performing additional duties as required based on business needs.

Essential Duties and Job Functions

• Analyze and interpret manufacturing and production data to support decision-making.
• Investigate process deviations and implement corrective actions.
• Execute validation and verification protocols in compliance with quality standards.
• Collaborate with cross-functional teams including Engineering, Quality, and IT systems.
• Support document control and ensure compliance with quality management systems.
• Participate in audits and ensure readiness for regulatory inspections.
• Troubleshoot technical and process-related issues in production environments.
• Contribute to continuous improvement and operational excellence initiatives.

Knowledge & Skills

• Strong analytical and problem-solving skills.
• Excellent organizational skills with high attention to detail and accuracy.
• Ability to work independently and collaboratively in a team environment.
• Effective verbal and written communication skills.
• Ability to manage ambiguity and work in a fast-paced environment.
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
• Strong troubleshooting and technical aptitude.
• Familiarity with quality systems and manufacturing processes is a plus.

Education & Experience

Required:

• High school diploma or GED

Preferred:

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

Experience:

• 0-2 years of relevant experience (entry-level candidates encouraged to apply)
• Experience with quality systems (e.g., SOPs, DHRs, ECOs, GLP, GMP) is a plus
• Familiarity with ERP systems (e.g., SAP) is desirable
• Hands-on experience with clinical or diagnostic instrumentation (e.g., DNA sequencing or similar technologies) is highly preferred