Contract QC Data Integrity & Compliance Specialist

Spectraforce Technologies, Inc.

Waldorf (MD)

On-site

USD 55,000 - 83,000

Full time

5 days ago
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Job summary

Spectraforce Technologies, Inc. is seeking a QC Compliance & Data Review Specialist III (Contract) to join the Frederick, MD quality control organization.

The role focuses on managing QC compliance records and performing independent review of laboratory and quality data to ensure accuracy, traceability, and data integrity in a GMP environment. The position requires coordination with QC Ops, QA, Manufacturing, and other stakeholders to support product disposition and inspection readiness.

Qualifications

  • Master's degree with 3+ years in GMP biologics/cell therapy
  • Bachelor's degree with 5+ years in GMP environment
  • High school diploma with 9+ years in GMP environment
  • Experience reviewing GMP lab data and managing quality records

Responsibilities

  • Manage QC quality records in the Quality Management System
  • Monitor record progress, due dates and approvals
  • Review records for problem statements and root cause evaluation
  • Maintain inspection-ready records and retention requirements
  • Coordinate with owners and reviewers to close documentation gaps
  • Perform independent technical review of GMP data and supporting docs
  • Reconcile data across source records and systems
  • Identify discrepancies and escalate issues appropriately
  • Support review of COAs, release data packages, OOS/OOT investigations

Skills

cGMP knowledge
Data integrity
Record management
Documentation practices
Cross-functional collaboration

Education

Master's degree in science/tech
Bachelor's degree in science/tech
High school diploma with extensive GMP experience

Tools

GVault
Veeva
TrackWise
LabVantage

Job description

Spectraforce Technologies, Inc. is seeking a QC Compliance & Data Review Specialist III (Contract) to join the Frederick, MD quality control organization.

The role focuses on managing QC compliance records and performing independent review of laboratory and quality data to ensure accuracy, traceability, and data integrity in a GMP environment. The position requires coordination with QC Ops, QA, Manufacturing, and other stakeholders to support product disposition and inspection readiness.

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