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Manufacturing Specialist 1

Hayward, CA 94545

Posted: 09/18/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 583779 Is job remote?: No Country: United States

Job Description


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 Client 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 pFMEAas 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.
20-30 pay rate range
**salary will be commensurate with experience**
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About Hayward, CA

Discover exciting job opportunities in and around Hayward, California! Located in the East Bay area of the San Francisco Bay region, this bustling city offers the perfect blend of career growth and quality of life. With its close proximity to Silicon Valley, Hayward provides a gateway to endless possibilities in tech and innovation. Enjoy the stunning views of the San Francisco Bay, explore the Hayward Japanese Gardens, or catch a show at the historic Chabot Theater. Indulge in diverse cuisines from the local eateries or take a stroll through the Hayward Area Historical Society. Join us in Hayward for a thriving job market and a vibrant community waiting to welcome you with open arms. Explore our job listings today and embark on an exciting career journey in this charming city!

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