Data Analyst, Data Integrity

Certified Laboratories Inc•Kitchener, ON

66d

About The Position

We are seeking a Data Analyst to join our Data Integrity department. This role is responsible for ensuring the structural integrity, traceability, and defensibility of laboratory data systems, computational tools, and analytical method documentation. The position spans multiple domains of responsibility: Governance and configuration of Labstat’s custom LIMS master data Analytical test method validation reporting and review Development and maintenance of Method Summaries and Test Procedure Master Files (TPMFs) Validation and structured oversight of spreadsheet-based tools While these areas require distinct skill sets, they intersect where analytical method validation outputs drive LIMS configuration, calculation logic, and controlled method documentation. The role ensures that validated method parameters are correctly translated into system configuration and controlled documentation. Spreadsheet validation and design support, while critical to overall data integrity, operates as a parallel responsibility and does not necessarily derive from method validation activities. 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.

Requirements

BSc. or MSc with a focus on a chemistry and/or biology related field, or related scientific discipline
At least 3 years' experience working in a laboratory is a necessity.

Nice To Haves

Previous experience working in either a GLP or ISO17025 environment would be an asset.
Experience with LIMS configuration or laboratory data systems preferred.
Experience drafting or reviewing analytical method validation reports preferred.
Experience validating structured spreadsheets in a controlled environment preferred.

Responsibilities

LIMS Master Data Management
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.
Analytical Test Method Validation Reporting & Measurement Traceability
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.
Method Summaries & Tobacco Product Master File (TPMF)
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.
Spreadsheet Validation & Structured Design Support
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.