Quality Control Data Reviewer I: Precision & Compliance

Pharmaron Beijing Co. Ltd.; Germantown (MD); On-site; USD 68,000 - 75,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid PTO and holidays

Wellness programs

Professional development

Job summary

Pharmaron Beijing Co. Ltd. in Germantown, MD seeks a Quality Control Data Reviewer I to perform comprehensive QC data review for bioanalytical assays, ensuring accuracy, data integrity, and GLP/GCP compliance.

The role involves reviewing datasets, study reports, and documentation, and collaborating with analysts to resolve discrepancies in a regulated lab environment. The position emphasizes attention to detail, strong communication, and proficiency with LIMS, TrackWise, and Excel.

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 in a Quality Control or Quality Assurance role within a bioanalytical laboratory is preferred.
• Experience in a regulated laboratory environment.
• Knowledge of GLP, GCP, 21 CFR Part 11, 21 CFR Part 58, and ICH guidelines.
• Strong written and verbal communication skills.
• Ability to work independently and collaborate with scientists and cross-functional teams.

Responsibilities

• Perform comprehensive quality review of bioanalytical assay data for accuracy, completeness, data integrity, and GLP/GCP compliance.
• Review datasets from method development, method validation, and sample analysis studies.
• Review study reports, protocols, amendments, and supporting documentation for accuracy and compliance.
• Review sample management documentation and verify proper documentation and storage in LIMS.
• Review calibration records, logbooks, and other quality documentation.
• Maintain QC review records in accordance with SOPs and best practices.
• Initiate and coordinate quality events in TrackWise with Lead Scientists.
• Communicate review findings and study status to management and internal teams.
• Support development and revision of SOPs, work instructions, methods, and training materials.
• Assist with training and mentoring team members.
• Track QC metrics to identify errors and drive continuous improvement.
• Support audits and ensure compliance with regulatory requirements.

Skills

Quality data review

GLP/GCP knowledge

Attention to detail

Strong communication

Excel

LIMS

TrackWise

Smartsheet

Education

Bachelor's degree in a scientific field

Tools

LIMS

TrackWise

Smartsheet

Excel

Job description

Pharmaron Beijing Co. Ltd. in Germantown, MD seeks a Quality Control Data Reviewer I to perform comprehensive QC data review for bioanalytical assays, ensuring accuracy, data integrity, and GLP/GCP compliance.

The role involves reviewing datasets, study reports, and documentation, and collaborating with analysts to resolve discrepancies in a regulated lab environment. The position emphasizes attention to detail, strong communication, and proficiency with LIMS, TrackWise, and Excel.