QC Data Integrity & Compliance Specialist (Contract)

ATR International; Frederick (MD); On-site; USD 75,000 - 110,000; Full time

Job summary

ATR International seeks a QC Compliance & Data Review Specialist III (Contract) in Frederick, MD to manage quality records and perform independent review of laboratory data, ensuring ALCOA+ principles and regulatory compliance. The role partners with QA, Manufacturing, and cross-functional teams to support inspection readiness and continuous improvement.

This temporary assignment lasts approximately four to six months, focusing on timely product disposition, data integrity, and robust

Qualifications

• Strong knowledge of cGMP, data integrity, and 21 CFR Parts 11, 210, 211.
• Ability to review complex lab data and generate evidence-based conclusions.
• Experience with electronic quality management and LAB systems.

Responsibilities

• Manage QC records in the QMS, incl. deviations, investigations, CAPAs, and change controls.
• Perform independent review of GMP lab data and supporting docs.
• Ensure ALCOA+ data integrity and traceability across records.
• Develop compliance trackers, dashboards, and trend reports.
• Support audits, inspections, and regulatory responses.

Skills

Data integrity

ALCOA+

cGMP knowledge

Documentation practices

Root cause analysis

Data review

Communication

Analytical skills

Education

Master's degree in a scientific/technical discipline

Bachelor's degree in a scientific/technical discipline

High school diploma with extensive GMP experience

Tools

GVault

Veeva

TrackWise

LabVantage

Job description

ATR International seeks a QC Compliance & Data Review Specialist III (Contract) in Frederick, MD to manage quality records and perform independent review of laboratory data, ensuring ALCOA+ principles and regulatory compliance. The role partners with QA, Manufacturing, and cross-functional teams to support inspection readiness and continuous improvement.

This temporary assignment lasts approximately four to six months, focusing on timely product disposition, data integrity, and robust