Evening QC Data Reviewer II

Tolmar-7; Fort Collins (CO); On-site; USD 65,000 - 90,000; Full time

Job summary

Tolmar is seeking a QC Data Reviewer II to perform data review ensuring laboratory results meet cGMP and ALCOA+ standards. The role includes reviewing documentation, logs, calibration, and instrument settings to maintain data integrity and compliance with SOPs.

Responsibilities include approving audit trails, resolving discrepancies, and supporting training while contributing to Lean lab initiatives and electronic systems implementations. This is an on-site position in Fort Collins.

Qualifications

• Bachelor’s Degree in science or related field.
• Two or more years of analytical laboratory experience and/or data review in a pharmaceutical environment.
• Working understanding of FDA regulations, USP, NF, ICH, EP and related compendia.

Responsibilities

• Review data for compliance with methods, work instructions, and SOPs.
• Evaluate testing results against specifications and suitability requirements.
• Ensure ALCOA+ data integrity and documentation.
• Review logbooks, calibration records, and instrument settings.
• Approve audit trails and metadata; resolve discrepancies.
• Generate standard forms and perform routine calculations.
• Review daily verifications and sample submission paperwork.
• Authorize data in notebooks and repositories (Endeavor and LIMS).
• Train and assist analysts; participate in process improvements.

Skills

HPLC

GC

FTIR

pH

UV-Vis

TLC

Karl Fischer

Rheometry

Wet chemistry

LIMS experience

MS Office

Electronic document mgmt

Education

Bachelor’s Degree in science

Tools

LIMS

Electronic document mgmt

MS Office

Job description

Tolmar is seeking a QC Data Reviewer II to perform data review ensuring laboratory results meet cGMP and ALCOA+ standards. The role includes reviewing documentation, logs, calibration, and instrument settings to maintain data integrity and compliance with SOPs.

Responsibilities include approving audit trails, resolving discrepancies, and supporting training while contributing to Lean lab initiatives and electronic systems implementations. This is an on-site position in Fort Collins.