Data Analyst, Data Integrity

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

Data Analyst, Data Integrity 

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.

Primary responsibilities of the job:

1. LIMS Master Data Management

1. 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
2. Verify that calculation logic implemented in LIMS accurately reflects approved methods.
3. Maintain documentation supporting configuration changes, traceability, and version control.
4. Identify structural risks or inconsistencies in requested configurations and recommend action.
5. Collaborate with laboratory operations, quality, and IT to ensure system integrity.

2. Analytical Test Method Validation Reporting & Measurement Traceability

1. Draft and/or perform technical review of analytical method validation reports.
2. 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).
3. 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
4. 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.
5. Identify inconsistencies between executed experiments, statistical treatment, and reported conclusions.
6. Ensure validation documentation is technically defensible and audit-ready.

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

3. Method Summaries & Tobacco Product Master File (TPMF)

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

4. Spreadsheet Validation & Structured Design Support

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

Note: Spreadsheet validation activities operate independently of method validation reporting, although alignment with approved method requirements must be confirmed where applicable.

Minimum Qualifications:

1. BSc. or MSc with a focus on a chemistry and/or biology related field, or related scientific discipline
2. At least 3 years' experience working in a laboratory is a necessity.  Previous experience working in either a GLP or ISO17025 environment would be an asset.
3. Experience with LIMS configuration or laboratory data systems preferred.
4. Experience drafting or reviewing analytical method validation reports preferred.
5. Experience validating structured spreadsheets in a controlled environment preferred.

What we Offer:

• Competitive wages
• Benefits
• RRSP Matching
• TFSA’s
• Training Programs
• Social events

Labstat values a diverse workforce.

Labstat values Equal Opportunity and embraces diversity. Begin a dynamic and rewarding career by becoming a member of Labstat’s team of professionals!

Labstat is committed to meeting the accessibility requirements under the AODA and we invite applicants to contact us for specific requirements.