Laboratory Support Analyst; LIMS

Laboratory Support Analyst (Data Analyst, Data Integrity)

Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.

As a result of our continuing growth, Labstat has the following employment opportunity available:

This position requires technical rigor, structured thinking, and the ability to critically evaluate data systems and analytical documentation. It is a governance and oversight function—not a clerical reporting role.

• Configure and maintain master data within Labstat’s custom LIMS, including:
  • Test code setup and maintenance
  • Calculation block request evaluation, implementation, and independent validation
  • Base table management and controlled data structure maintenance
• Verify that calculation logic implemented in LIMS accurately reflects approved methods.
• Maintain documentation supporting configuration changes, traceability, and version control.
• Identify structural risks or inconsistencies in requested configurations and recommend action.
• Collaborate with laboratory operations, quality, and IT to ensure system integrity.

• Draft and/or perform technical review of analytical method validation reports.
• Confirm validation protocols appropriately evaluate required performance characteristics (e.g., accuracy, precision, linearity, range, specificity, detection limits, quantitation limits, robustness, and measurement uncertainty as applicable).
• Independently assess statistical analyses supporting validation conclusions, including examples such as:
  • Precision calculations (repeatability and intermediate precision)
  • Bias and recovery assessments
  • Limit calculations (LOD/LOQ) and supporting justification
• Ensure complete measurement traceability by verifying that:
  • Reported results trace directly to raw analytical data.
  • All calculations are independently verified and aligned with approved system logic.
• Identify inconsistencies between executed experiments, statistical treatment, and reported conclusions.
• Ensure validation documentation is technically defensible and audit-ready.

Validated method parameters must be accurately translated into LIMS configuration, calculation blocks, reporting limits, and controlled documentation (Method Summaries and TPMFs).

• Develop, revise, and maintain Method Summaries and TPMF.
• Ensure alignment between:
  • Approved analytical procedures
  • Validated performance characteristics
  • Reporting conventions and rounding practices
• Maintain document version control and traceability.
• Identify and resolve discrepancies between documented procedures and system configuration prior to release.

• Validate spreadsheets used for laboratory calculations in accordance with internal data integrity standards.
• Perform detailed formula verification, logic tracing, stress testing, and boundary condition assessments.
• Identify structural risks in user-developed spreadsheets and recommend improvements.
• Ensure documentation and validation records are maintained for spreadsheet tools operating within scope.

Note:

Spreadsheet validation activities operate independently of method validation reporting, although…