Cell Therapy QC Data Review Specialist (Contract)

Planet Pharma; Frederick (MD); On-site; USD 44,000 - 52,000; Full time

Job summary

Planet Pharma in Frederick, MD seeks a QC Compliance & Data Review Specialist III on a contract basis to manage QC records and independently review laboratory data for GMP compliance and data integrity.

The role partners with QC Operations, QA, Manufacturing, and cross-functional teams to ensure inspection readiness and timely product disposition, with a duration of four to six months.

Qualifications

• Master’s degree or equivalent with GMP experience.
• Bachelor’s degree with GMP experience in biologics or cell therapy.
• High school diploma with extensive GMP-related experience.

Responsibilities

• Manage QC quality records in the Quality Management System.
• Perform independent review of GMP data and records for ALCOA+ compliance.
• Identify data integrity concerns and escalate issues.
• Prepare evidence packages for management review and inspections.
• Support inspections and regulatory inquiries.

Skills

QC Data Review

ALCOA+ Principles

Data Integrity

Documentation Practices

Regulatory Compliance

Education

Master’s degree in a relevant scientific or technical discipline

Bachelor’s degree in a relevant scientific or technical discipline

High school diploma or equivalent

Tools

GVault

Veeva

TrackWise

LabVantage

Microsoft Office

Job description

Planet Pharma in Frederick, MD seeks a QC Compliance & Data Review Specialist III on a contract basis to manage QC records and independently review laboratory data for GMP compliance and data integrity.

The role partners with QC Operations, QA, Manufacturing, and cross-functional teams to ensure inspection readiness and timely product disposition, with a duration of four to six months.