DNA Sequencing Manufacturing Associate — Process & Quality

Planet Pharma; Hayward (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Planet Pharma in Hayward, CA is seeking a dedicated professional to provide technical and process support to the manufacturing team, ensuring production plans are met while upholding Quality Systems compliance.

You will analyze data to drive efficiency and quality, collaborate on process improvements, and serve as SME for validation plans, MES/eDHR changes, and quality document updates. Strong organizational skills and teamwork are essential.

Qualifications

• High school diploma or GED required; STEM coursework a plus.
• Some relevant college-level STEM courses or training are preferred.
• Bachelor's degree in Engineering, Chemistry, Biology or Physics is preferred.

Responsibilities

• Analyze production data to identify trends and drive efficiency, quality, and cost improvements.
• Collaborate with LCM and Process Engineering to resolve process discrepancies.
• Provide SME support on Validation plans, verification and validation protocols, and released protocols.
• Act as SME during development and change management on MES and eDHR processes and systems with GIS, Process Engineering and Quality.
• Assist in creating or updating Quality Documents such as work instructions, procedures, pfMEAs, validation test reports, batch records, and test methods.
• Participate in continuous improvement projects using Operational Excellence and Lean Six Sigma tools.
• Support internal manufacturing audits and assist with corrective actions and responses.
• Test next-gen DNA sequencing instrumentation using released procedures.
• Troubleshoot product non-conformances with Manufacturing, Quality, and LCM.
• Establish and maintain reports on instrument failures and defects.

Skills

Analytical thinking

Attention to detail

Team collaboration

Communication skills

Education

High school diploma or GED

STEM coursework or training

Bachelor's degree in Engineering/Chemistry/Biology/Physics

Tools

Microsoft Office (Excel, Word, PowerPoint)

SAP ERP systems

Job description

Planet Pharma in Hayward, CA is seeking a dedicated professional to provide technical and process support to the manufacturing team, ensuring production plans are met while upholding Quality Systems compliance.

You will analyze data to drive efficiency and quality, collaborate on process improvements, and serve as SME for validation plans, MES/eDHR changes, and quality document updates. Strong organizational skills and teamwork are essential.