QC Compliance & Data Review Lead (Contract)

ACL Digital; Frederick (MD); On-site; USD 62,000 - 103,000; Full time

Job summary

ACL Digital in Frederick, MD seeks a QC Compliance & Data Review Specialist III (Contract) to manage QC quality records and perform independent data reviews in a GMP environment. This role supports cell therapy operations, requires strong documentation practices, and collaborates with QA, Manufacturing, and Technical Operations to ensure inspection readiness.

The position is a 6+ month contract with standard M-F hours.

Qualifications

• Master's degree in a relevant scientific or technical discipline with 3+ years in GMP/biologics or cell therapy; or
• Bachelor's degree with 5+ years in GMP; or
• High school diploma with 9+ years in GMP environment.

Responsibilities

• Manage and own QC quality records in the Quality Management System (deviations, investigations, CAPAs, change controls).
• Review GMP laboratory data for accuracy, traceability, and data integrity.
• Develop and maintain compliance trackers, dashboards, and trend reports for quality records and data review.
• Author, revise, and review SOPs and training materials supporting QC compliance and data review.
• Train and mentor QC personnel on record quality and data integrity.

Skills

cGMP knowledge

GxP data integrity

Documentation practices

MS Office proficiency

Regulatory awareness

Communication skills

Education

Master's degree in a relevant field

Bachelor's degree in a relevant field

High school diploma or equivalent

Tools

GVault

Veeva

TrackWise

LabVantage

Job description

ACL Digital in Frederick, MD seeks a QC Compliance & Data Review Specialist III (Contract) to manage QC quality records and perform independent data reviews in a GMP environment. This role supports cell therapy operations, requires strong documentation practices, and collaborates with QA, Manufacturing, and Technical Operations to ensure inspection readiness.

The position is a 6+ month contract with standard M-F hours.