Quality Assurance Lead

2 weeks ago


San Francisco, United States IT Compliance Solutions Full time

Company Description

IT Compliance Solutions is a leading provider of implementation and validation services for Laboratory and Quality Informatics solutions. Our expertise lies in navigating complex implementations, validations, and regulations of IT Quality Management Systems (QMS and LMS) and Lab Informatics Solutions such as LIMS/ELN/CDS. We support organizations in making informed decisions when evaluating and selecting GxP Computerized Systems.


Role Description

This is a hybrid contract role for a Benchling LIMS R&D QA Validation Lead/Specialist. The QA Validation Lead/Specialist will be responsible for conducting quality control and assurance activities, managing quality management systems, performing Good Manufacturing Practice (GMP) audits, and ensuring compliance with regulatory requirements. The QA Validation Lead/Specialist will collaborate with cross-functional teams to ensure the successful implementation and validation of Benchling LIMS R&D software.


Qualifications

  • Quality Control, Quality Assurance, and Quality Management skills
  • Experience with Good Manufacturing Practice (GMP)
  • Expertise in quality auditing and regulatory compliance
  • Experience in Research and Development (R&D)



Relevant skills and qualifications critical for this role include and that are a Must Have:


  • 7 plus years of experience with Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN)
  • 7 plus years of knowledge of Computerized System Validation (CSV) and Data Integrity
  • Benchling LIMS R& D Experience
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Attention to detail and accuracy
  • Ability to work independently and remotely
  • Bachelor's degree in a relevant field (e.g., Biology, Chemistry, Computer Science)





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