What are the responsibilities and job description for the LIMS Compliance Validation Specialist position at CONFLUX SYSTEMS?
Description
You will play a key role in system validation, focusing on the intricate aspects of LIMS (Laboratory Information Management Systems) and CSV (Computer System Validation). Your responsibilities will include collaborating with cross-functional stakeholders on large and complex system validation projects. You will leverage your extensive knowledge of LabVantage LIMS, JIRA, and EDMS to support these initiatives.
Your expertise in regulatory requirements for both product and non-product software, including standards such as 21 CFR Part 11, Part 820, Annex 11, and IEC 62304, will be crucial in addressing CSV-related regulatory and compliance inquiries. The role demands a deep understanding of QA methodologies, test planning, system dependencies, and software SDLC phases.
Skills
06-12 months with a possible extension.
Location
100% Remote.
Employment Type: Contractor
You will play a key role in system validation, focusing on the intricate aspects of LIMS (Laboratory Information Management Systems) and CSV (Computer System Validation). Your responsibilities will include collaborating with cross-functional stakeholders on large and complex system validation projects. You will leverage your extensive knowledge of LabVantage LIMS, JIRA, and EDMS to support these initiatives.
Your expertise in regulatory requirements for both product and non-product software, including standards such as 21 CFR Part 11, Part 820, Annex 11, and IEC 62304, will be crucial in addressing CSV-related regulatory and compliance inquiries. The role demands a deep understanding of QA methodologies, test planning, system dependencies, and software SDLC phases.
Skills
- Preferred experience with LabVantage LIMS, JIRA, and EDMS.
- Strong knowledge of regulatory requirements for software validation.
- Extensive understanding of QA methodologies, testing strategies, and software development lifecycle.
- Excellent task execution capabilities and problem-solving skills.
- Strong communication skills, enabling effective teamwork and independent work.
06-12 months with a possible extension.
Location
100% Remote.
Employment Type: Contractor
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