Description

Excel in the Role of LIMS CSV Specialist

Duration: 06-12 Months with potential for extension

Location: 100% Remote

Job Summary

Join our dynamic team as a LIMS CSV Specialist! This role requires an individual with a strong background in LabVantage LIMS, JIRA, and EDMS. As a LIMS CSV Specialist, you will collaborate with cross-functional stakeholders to ensure the successful validation of large and complex systems. Your knowledge of regulatory requirements for non-product and product software, along with your ability to respond to CSV-related regulatory and compliance inquiries, will be essential to your success in this role.

Responsibilities

 

  • Utilize your expertise in LabVantage LIMS, JIRA, and EDMS to support the validation of complex systems.
  • Collaborate with cross-functional stakeholders to ensure accurate and efficient system validation.
  • Respond to CSV-related regulatory and compliance inquiries by leveraging your understanding of regulatory requirements for non-product and product software (e.g., 21 CFR Part 11, part 820, Annex 11, IEC 62304, etc.).
  • Apply extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases to drive successful system validation.
  • Demonstrate excellent task execution skills and the ability to work both independently and as part of a team.
  • Communicate effectively with stakeholders, demonstrating strong written and verbal communication skills.

     

Requirements

 

  • Comprehensive understanding of LabVantage LIMS, JIRA, and EDMS.
  • Knowledge of regulatory requirements for non-product and product software, such as 21 CFR Part 11, part 820, Annex 11, IEC 62304, etc.
  • Demonstrated experience in QA methodologies, test planning, system dependencies, and software SDLC phases.
  • Excellent task execution skills and the ability to work independently and collaboratively.
  • Strong communication skills, both written and verbal.

     

Join our team as a LIMS CSV Specialist and be part of a collaborative and innovative environment where your expertise will make a significant impact. Are you ready to excel in this role and contribute to the success of our organization? Apply now!

Employment Type: Contractor

Key Skills
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