Apply on Employer Site

Guerbet · 1 day ago

QC Data Reviewer

Raleigh, NC

Full-time

Onsite

Senior Level

7+ years exp

Guerbet is a company focused on the pharmaceutical industry, and they are seeking a QC Data Reviewer. The role involves conducting GMP/GDP data reviews of laboratory analyses, ensuring compliance with test methods and SOPs, and authoring laboratory investigation reports.

Health CareMedicalPharmaceutical

Hiring Manager

Kris Adams

Responsibilities

Audit and approve laboratory data and reports (including wet chemistry and HPLC data)

Ensure sample data is correctly input into LIMS as required

Author lab investigations in relation to invalid or out-of-specification results (with input from analysts)

Review equipment logbooks periodically to ensure continued validated state of instrumentation

Assist in sample tracking and update sample database when samples are released from the lab

Ensures laboratory analyses are performed in accordance with GMP/GDP practices

Assures data integrity and ALCOA standards are applied to all laboratory data

Responsible for authoring laboratory investigations (invalidations, out-of-specifications) with input from analysts

Assist analysts in determining a root cause for aberrant results

Responsible for making sure samples released from the lab are tracked in the lab database

Responsible for reviewing equipment logbooks

Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately

Support various information requests from other departments

Assist Lab Supervisors/Manager with tracking investigation and testing cycle times

Other duties as assigned with or without accommodation

Qualification

GMP/GDP complianceHPLC analysisLaboratory investigation writingLIMS proficiencyDocumentation skillsComputer competencyAttention to detailFast-paced environment adaptability

Required

Responsible for conducting GMP/GDP data review of laboratory analyses and associated write-up documentation (including but not limited to wet chemistry and HPLC analysis)

The Quality Data Reviewer will assure the analysts' adherence to test methods, SOPs, etc. when reviewing data, and that data integrity was maintained throughout the testing process

The Quality Data Reviewer will also author laboratory investigation reports (i.e. invalidation and OOS reports)