Demo

QC Electronic Systems Specialist

Rangam
Summit, NJ Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/3/2025

We are seeking a QC Electronic Systems Specialist responsible for creating, deploying, and sustaining electronic systems Master Data , including LIMS, ERP, and MES . The ideal candidate will have strong experience in computer system validation, operational support, and system integration within a regulated environment.

Key Responsibilities :

  • Create and execute computer system validation documents (UAT, URS, OQ, PQ, etc.).
  • Develop, verify, and sustain Master Data for LIMS, ERP, and MES.
  • Provide operational support and troubleshoot issues for end users.
  • Propose and implement improvements to optimize system performance.
  • Lead CAPA, deviation investigations, and continuous improvement efforts.
  • Support QC management in strategic planning and long-term business needs.
  • Train and mentor end users on electronic system use and best practices.
  • Translate business requirements into technical solutions and collaborate with IT.
  • Serve as Subject Matter Expert (SME) during health agency inspections.

Required Qualifications :

  • Bachelor’s degree in Science or Engineering (preferred).
  • 6 years of experience in LIMS, ELN, and laboratory data analysis systems.
  • Strong knowledge of analytical and microbiological test methods.
  • Experience in validation and maintenance of laboratory information systems.
  • Excellent problem-solving, communication, and technical writing skills.
  • Ability to interpret and apply cGMP and global regulatory requirements.
  • Strong skills in mentoring, coaching, and cross-functional collaboration.
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