QC Data Reviewer II — Data Integrity & Compliance (Evening Shift)

Tolmar Inc.; Fort Collins (CO); On-site; USD 65,000 - 88,000; Full time

Job summary

Tolmar Inc. is seeking a QC Data Reviewer II to ensure laboratory data quality under cGMP and ALCOA+ guidelines. You will review data, audit trails, and metadata, and authorize sample data in notebooks and repositories, supporting continuous process improvements.

The role requires familiarity with analytical instruments, data management systems, and collaboration with analysts to maintain high data integrity and quality in a pharmaceutical environment.

Qualifications

• Bachelor’s degree in science or related field is required.
• Two or more years of analytical laboratory experience and/or data review in a pharmaceutical environment is preferred.
• Experience with HPLC, GC, FTIR, pH, UV-Vis, TLC, Karl Fischer titration and rheometry.
• Able to review laboratory data against specifications and SOPs with accuracy.

Responsibilities

• Review and approve laboratory data and audit trails to ensure data integrity.
• Evaluate testing results against applicable specifications and suitability requirements.
• Review logbooks, materials, equipment calibration and instrument settings.
• Authorize data in notebooks and data repositories (Endeavor and LIMS).
• Assist with training of analysts and reviewers and help prepare SOPs and training documents.
• Participate in process improvement initiatives and lean lab principles.

Skills

Wet chemistry techniques

Data review

Electronic document management

LIMS experience

MS Office

Education

Bachelor's Degree in science

2+ years analytical lab data review

Tools

LIMS

Electronic lab notebooks

MS Office

Job description

Tolmar Inc. is seeking a QC Data Reviewer II to ensure laboratory data quality under cGMP and ALCOA+ guidelines. You will review data, audit trails, and metadata, and authorize sample data in notebooks and repositories, supporting continuous process improvements.

The role requires familiarity with analytical instruments, data management systems, and collaboration with analysts to maintain high data integrity and quality in a pharmaceutical environment.