Quality Control Data Reviewer I — Bioanalytical QC Excellence

Pharmaron

Germantown (MD)

On-site

USD 68,000 - 75,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid Time Off & Holidays

HSA contributions

Job summary

Pharmaron in Germantown, MD is seeking a Quality Control Data Reviewer I to perform comprehensive QC data reviews and ensure GLP/GCP compliance. The role involves evaluating bioanalytical assay data, review of method development, validation, and sample analysis documentation.

You will coordinate QC events in TrackWise, maintain records, and collaborate with analysts and cross-functional teams. A bachelor’s degree in a relevant scientific field and strong Excel/LIMS skills are required, with

Qualifications

Bachelor's degree in a relevant scientific field.
QC Data Reviewer I: Some laboratory or quality experience.
QC Data Reviewer II: 2+ years of relevant quality experience.
QC Data Reviewer III: 5+ years of relevant quality experience.
Experience with GLP, GCP, 21 CFR Part 11, 21 CFR Part 58, and ICH guidelines.
Experience with LIMS, quality management systems, and TrackWise preferred.
Strong attention to detail, organizational skills, critical thinking, and problem-solving abilities.

Responsibilities

Perform comprehensive quality review of bioanalytical assay data for accuracy, completeness, data integrity, and compliance with GLP/GCP requirements, study protocols, SOPs, and client expectations.
Review datasets generated from method development, method validation, and sample analysis studies.
Review study reports, protocols, protocol amendments, and supporting documentation for accuracy and compliance.
Review sample management documentation and verify samples are appropriately documented and stored in LIMS.
Review laboratory equipment calibration records, logbooks, and other quality documentation.
Maintain accurate QC review records in accordance with SOPs and quality best practices.
Coordinate quality events in TrackWise with Lead Scientists.
Communicate with management and internal departments regarding data review findings and study status.
Support the development and revision of SOPs, work instructions, methods, study plans, and training materials.
Assist with training and mentoring team members as appropriate to experience level and qualification.
Track QC metrics, identify recurring errors or trends, and contribute to continuous improvement initiatives.