Senior QC Compliance & Data Review Specialist

United Pharma; Maryland; On-site; USD 85,000 - 120,000; Full time

Job summary

United Pharma in Frederick, Maryland is seeking a QC Compliance & Data Review Specialist III on a contract basis for approximately four to six months. The role focuses on managing QC compliance records and independently reviewing GMP data to ensure accuracy, traceability, and data integrity per ALCOA+ principles.

The position collaborates with QC Operations, QC Technical Services, QA, and Manufacturing to support commercial cell therapy operations, inspection readiness, and continuous

Qualifications

• Advanced degree with 3+ years in a biologics, cell therapy, or GMP environment.
• Experience reviewing GMP laboratory data and managing quality records (deviations, CAPAs, change controls).
• Working knowledge of electronic Quality Management Systems and Laboratory Information Management Systems.
• Familiarity with data integrity concepts and ALCOA+ principles.

Responsibilities

• Compliance Records Management: manage QC quality records in the QMS, including deviations, investigations, CAPAs, changes, and impact assessments.
• Data Review and Data Integrity: conduct independent reviews of GMP data, verify completeness, traceability, and documentation quality.
• Compliance Oversight and Reporting: develop trackers, dashboards, metrics, and trend reports for QC activities.
• Procedures, Training and Continuous Improvement: author and update SOPs, train QC staff, and drive cross‑functional improvements.

Skills

cGMP

Good Documentation Practices

Data integrity

ALCOA+

Data review

Regulatory compliance

Cross-functional collaboration

Attention to detail

Education

Master's degree in a relevant field

Bachelor's degree in a relevant field

High school diploma with GMP experience

Tools

GVault

Veeva

TrackWise

LabVantage

Job description

United Pharma in Frederick, Maryland is seeking a QC Compliance & Data Review Specialist III on a contract basis for approximately four to six months. The role focuses on managing QC compliance records and independently reviewing GMP data to ensure accuracy, traceability, and data integrity per ALCOA+ principles.

The position collaborates with QC Operations, QC Technical Services, QA, and Manufacturing to support commercial cell therapy operations, inspection readiness, and continuous