Job Description
Title: Manufacturing Specialist
Pay: $25.00-$31.00/hour
Location: Hayward, CA (Onsite)
Duration: 6-Month Contract
Schedule: 1st Shift (8-hour days; flexible start between 6:00 AM - 8:00 AM)
Job Description
Position Summary:
This role provides technical and process support to the manufacturing team to ensure production goals are met while maintaining quality, efficiency, and compliance with established quality systems.
Key Responsibilities
- Analyze production data to identify trends and recommend actions that improve efficiency, product quality, and cost.
- Identify process gaps and collaborate with engineering teams to drive improvements.
- Support validation activities as a subject matter expert, including reviewing validation plans, executing protocols, and ensuring validated state is maintained.
- Serve as an SME for MES and eDHR systems; collaborate with cross-functional teams during development and change management.
- Create, update, and support Quality Documents such as SOPs, work instructions, pFMEAs, test methods, batch record templates, and validation reports.
- Participate in continuous improvement initiatives using Lean and Operational Excellence methodologies.
- Contribute to internal audit activities and assist with corrective actions and audit responses.
- Test next-generation instrumentation using approved procedures.
- Troubleshoot product non-conformances and work closely with Manufacturing, Quality, and Life Cycle Management to resolve issues.
- Maintain reports tracking instrument failures and defects.
- Perform other duties as assigned.
Required Education
- High School Diploma or GED.
- Some college-level STEM coursework or related technical training preferred.
Preferred Background & Skills
- Bachelor's degree in Engineering, Chemistry, Biology, Physics, or related field preferred.
- No prior technical experience required; detailed instructions will be provided.
- Strong organizational skills and attention to detail.
- Ability to work both independently and collaboratively in a team environment.
- Strong communication and troubleshooting skills.
- Proficient with Microsoft Office (Excel, Word, PowerPoint).
- Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP is a plus.
- Hands-on experience with diagnostic or sequencing instrumentation is highly desirable.