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Manufacturing Specialist 1

Planet Pharma Group · planet-pharma.com
HaywardEntry level
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The job in short

Manufacturing production specialist work.

ExcelSAPAuditClinicalCompliance

Details

Found
9 d ago · posted 2026-10-25
Location
Hayward, CA

Full description

Pay 31/h Job Summary: Responsible for technical and process support to the manufacturing team in order to effectively achieve production plans while maintaining quality and compliance to Quality Systems Tasks and responsibilities: • Analyze production data to determine trends and define actions to improve efficiency, product quality and cost. • Identify process discrepancies and collaborate with LCM and Process Engineering for improvement. • Support maintaining the validated state by providing SME support on Validation plans, verification and validation protocols and executing on released protocols. • Act as SME during development and change management on MES and eDHR process and systems by collaborating with GIS, Process Engineering and Quality. • Support development and in some cases create or modify Quality Documents such as; work instructions, procedures, pFMEA’s validation test reports, batch record templates and test methods. • Proactively participate on continuous improvement teams and projects using techniques from Operational Excellence and Lean Six Sigma methodologies. • Participate in manufacturing internal audit program and assist with corrective actions and audit responses. • Test next generation DNA sequencing instrumentation using released procedures and processes. • Troubleshoot and process non-conformances of products while collaborating with Manufacturing, Quality and Life Cycle Management. • Establish and maintain reports of instrument failures and defects. • Other duties as needed. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Required educational background: • High school diploma, GED. • Some relevant college level STEM courses or training are a plus. Preferred educational background: • Bachelors (BA/BS) in Engineering, Chemistry, Biology, Physics. Preferred experiential background: • Typically requires no previous technical experience. • Normally receives detailed instructions on all work. • Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential. • Ability to collaborate on multifunctional teams and manage ambiguity. • Strong interpersonal, verbal and written communication skills. • Excellent troubleshooting skills required. • Proficiency with Microsoft Office Tools (Excel, Word, and PowerPoint) • Experience with SOPs, DHRs, ECOs, GLP, GMP and SAP ERP systems is a plus. • Hands on experience with clinical/diagnostic instrumentation including DNA sequencing or equivalent is highly desirable.

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