QC Systems Analyst
Job DescriptionThe QC Systems Analyst role is a function of the Quality Control unit responsible for administration of the Labvantage Medical Device Laboratory Information Management System (MDLIMS).
The position is responsible for first line of support for system end users.
The role administrates system configuration, interfaced systems, master data and user login accounts as well the associated laboratory instrumentation.
dministrates the LabVantage 8 application to maintain and enhance the system configuration while maintaining the system's validated state.
Track, assess and disposition of enhancements, bug fixes and general user questions.
Scheduling, testing and releasing master data for Analytical, Incoming Inspection and Microbiology Labs.
Gather, analyze, document and validates business and user requirements while maintaining system life cycle documents.
Provides operational support and data analysis/trending for LIMS and other laboratory data systems.
Follows established change control procedures for SOP changes, system technical changes and master data changes.
Provides support for laboratory computers and instruments.
Performs investigations, root cause analysis, correction/preventive action plans.
Develops training materials and delivers training to system end users.
Minimum Required:
LIMS and/or ELN experience with:
QC related instrument/application experience (preferably support experience) Solid knowledge of quality control systems, FDA compliance, standards, regulations, and guidelines.
Understanding of HPLC, UV-VIS, FTIR, and titration instruments.
Excellent organizational and teamwork skills.
Excellent oral and technical writing skills.
Excellent level of written and spoken English required.
Proficiency in MS Word and MS Excel.
Preferred Level:
Minimum requirements plus experience with LabVantage application and database knowledge.
Recommended Skills Administration Chromatography Data Analysis Data System Databases English Estimated Salary: $20 to $28 per hour based on qualifications.
The position is responsible for first line of support for system end users.
The role administrates system configuration, interfaced systems, master data and user login accounts as well the associated laboratory instrumentation.
dministrates the LabVantage 8 application to maintain and enhance the system configuration while maintaining the system's validated state.
Track, assess and disposition of enhancements, bug fixes and general user questions.
Scheduling, testing and releasing master data for Analytical, Incoming Inspection and Microbiology Labs.
Gather, analyze, document and validates business and user requirements while maintaining system life cycle documents.
Provides operational support and data analysis/trending for LIMS and other laboratory data systems.
Follows established change control procedures for SOP changes, system technical changes and master data changes.
Provides support for laboratory computers and instruments.
Performs investigations, root cause analysis, correction/preventive action plans.
Develops training materials and delivers training to system end users.
Minimum Required:
LIMS and/or ELN experience with:
QC related instrument/application experience (preferably support experience) Solid knowledge of quality control systems, FDA compliance, standards, regulations, and guidelines.
Understanding of HPLC, UV-VIS, FTIR, and titration instruments.
Excellent organizational and teamwork skills.
Excellent oral and technical writing skills.
Excellent level of written and spoken English required.
Proficiency in MS Word and MS Excel.
Preferred Level:
Minimum requirements plus experience with LabVantage application and database knowledge.
Recommended Skills Administration Chromatography Data Analysis Data System Databases English Estimated Salary: $20 to $28 per hour based on qualifications.
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