Quality Control Data & Compliance Associate II

Maxonic Inc.; Frederick (MD); On-site; USD 44,000 - 63,000; Full time

Job summary

Maxonic is seeking a Quality Control Research Associate - II for a contract role in Frederick, Maryland, onsite, to support QC compliance, data review, and record management in a GMP environment for cell therapy operations and product disposition.

The candidate should have an advanced degree with 3+ years (or 5+ with a bachelor) in a regulated biotech setting, knowledge of data integrity, and experience with electronic quality systems and tools such as GVault, Veeva, TrackWise, or LabVantage.

Qualifications

• Master's degree in a relevant scientific or technical discipline with 3+ years of GMP experience.
• Bachelor's degree with 5+ years of relevant GMP biologics experience.
• High school diploma with 9+ years of relevant GMP experience.
• Experience reviewing GMP lab data and managing quality records such as deviations, investigations, CAPAs, and change controls.

Responsibilities

• Manage QC quality records in the Quality Management System, including deviations, investigations, CAPAs, change controls, and other records.
• Review records for clear problem statements, chronology, scientifically sound conclusions, root cause evaluation, and supporting evidence.
• Coordinate with record owners to resolve documentation gaps and drive timely closure.
• Perform independent technical review of GMP laboratory data, records, test worksheets, and supporting documentation.
• Develop and maintain compliance trackers, dashboards, and trend reports for QC performance indicators.
• Train and mentor QC personnel on data integrity and Good Documentation Practices.

Skills

Quality control

Data review

GMP

Data integrity

Documentation

Education

Master's degree in a relevant field

Bachelor's degree in a relevant field

High school diploma with years of GMP experience

Tools

GVault

Veeva

TrackWise

LabVantage

Job description

Maxonic is seeking a Quality Control Research Associate - II for a contract role in Frederick, Maryland, onsite, to support QC compliance, data review, and record management in a GMP environment for cell therapy operations and product disposition.

The candidate should have an advanced degree with 3+ years (or 5+ with a bachelor) in a regulated biotech setting, knowledge of data integrity, and experience with electronic quality systems and tools such as GVault, Veeva, TrackWise, or LabVantage.