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Laboratory Systems Validation Specialist I(m/w/x)
Leading system validations for LIS/LIMS and middleware platforms in a global laboratory services provider. 3+ years in a validation role with a BS degree required. Support client audits with system validation documentation.
Requirements
- 3+ years in Laboratory System Analyst or Validation role
- BS in Clinical Lab Science, Biology, Chemistry, Public Health, Microbiology, Computer, Technology, Animal Science, or Medical Technology
- 1+ years knowledge of lab workflow and processes
- 1+ years experience in laboratory software testing
- 1+ years experience supporting client audits with system validation documentation
- Experience in IT/Computer validation
- Experience in requirements gathering and documentation in regulatory environment
- Strong knowledge of 21 CFR Part 11 and CAP/CLIA regulations
- Background in information systems, data analysis, workflow analysis
- Effective communication with clients at all organizational levels
Tasks
- Operate and support laboratory instruments
- Support LIS/LIMS and middleware platforms
- Lead system validations for lab systems
- Guide team during system validations
- Support change control processes
- Collaborate with SMEs to define system behaviors
- Translate system behaviors into technical requirements
- Provide technical consultation to clients
- Gather and document system requirements
- Create and maintain validation documentation
- Lead testing activities for lab workflows
- Test physical automation and instrument middleware
- Oversee middleware interface development requirements
- Coordinate with project managers for system testing
- Ensure timely service delivery
- Maintain strong client relationships
- Drive client satisfaction
- Identify business opportunities
- Monitor system testing progress
- Track performance metrics
- Escalate issues as needed
- Review and prepare test results for QA
- Ensure complete and compliant test packages
- Balance operational and project duties
- Allocate resources to meet performance standards
- Maintain regulatory compliance
- Collaborate with other sites and teams
- Perform qualification specialist duties
- Review and approve validation documentation
- Archive validation documentation
- Provide updates to project managers and leadership
- Complete HR and training requirements
- Maintain an up-to-date training file
- Submit monthly status reports
- Support continuous improvement and quality
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Navify
- FCS Express
- Infinicyte
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Laboratory Systems Validation Specialist I(m/w/x)
Leading system validations for LIS/LIMS and middleware platforms in a global laboratory services provider. 3+ years in a validation role with a BS degree required. Support client audits with system validation documentation.
Requirements
- 3+ years in Laboratory System Analyst or Validation role
- BS in Clinical Lab Science, Biology, Chemistry, Public Health, Microbiology, Computer, Technology, Animal Science, or Medical Technology
- 1+ years knowledge of lab workflow and processes
- 1+ years experience in laboratory software testing
- 1+ years experience supporting client audits with system validation documentation
- Experience in IT/Computer validation
- Experience in requirements gathering and documentation in regulatory environment
- Strong knowledge of 21 CFR Part 11 and CAP/CLIA regulations
- Background in information systems, data analysis, workflow analysis
- Effective communication with clients at all organizational levels
Tasks
- Operate and support laboratory instruments
- Support LIS/LIMS and middleware platforms
- Lead system validations for lab systems
- Guide team during system validations
- Support change control processes
- Collaborate with SMEs to define system behaviors
- Translate system behaviors into technical requirements
- Provide technical consultation to clients
- Gather and document system requirements
- Create and maintain validation documentation
- Lead testing activities for lab workflows
- Test physical automation and instrument middleware
- Oversee middleware interface development requirements
- Coordinate with project managers for system testing
- Ensure timely service delivery
- Maintain strong client relationships
- Drive client satisfaction
- Identify business opportunities
- Monitor system testing progress
- Track performance metrics
- Escalate issues as needed
- Review and prepare test results for QA
- Ensure complete and compliant test packages
- Balance operational and project duties
- Allocate resources to meet performance standards
- Maintain regulatory compliance
- Collaborate with other sites and teams
- Perform qualification specialist duties
- Review and approve validation documentation
- Archive validation documentation
- Provide updates to project managers and leadership
- Complete HR and training requirements
- Maintain an up-to-date training file
- Submit monthly status reports
- Support continuous improvement and quality
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Navify
- FCS Express
- Infinicyte
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Labcorp
Industry
Healthcare
Description
The company is a leading global life sciences company that delivers answers for crucial health questions.
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