QC Compliance & Data Review Specialist III

Location: Frederick, MD

Responsibilities

• Communicate with QC Operations and cross-functional partners to coordinate data review, records completion, testing support, and resolution of quality-related issues.
• Monitor compliance with documented policies, applicable quality objectives, regulatory requirements, company procedures, and departmental practices.
• Review and interpret information contained in electronic and paper records, laboratory systems, reports, and controlled documents.
• Prepare and maintain accurate electronic records, written reports, metrics, presentations, and technical documentation.
• Use standard office and laboratory information systems for extended periods and participate in virtual or in-person meetings.

Requirements

• Master's degree in a relevant scientific or technical discipline and 3+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; OR Bachelor's degree in a relevant scientific or technical discipline and 5+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; OR High school diploma or equivalent and 9+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment.
• Experience reviewing GMP laboratory data and managing or supporting quality records such as deviations, laboratory investigations, CAPAs, and change controls.
• Strong working knowledge of cGMP, Good Documentation Practices, data integrity principles, and applicable regulatory requirements, including 21 CFR Parts 11, 210, and 211.
• Demonstrated ability to review complex laboratory and compliance records, recognize deviations from approved practices, and document clear, evidence-based conclusions.
• Working knowledge of root cause analysis, laboratory investigations, risk assessment, CAPA, change control, and inspection-readiness practices.

Benefits

• Medical insurance — PPO, HMO
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay

$61,934 – $77,418 (Dependent on Experience)

Skills

• Compliance
• Quality Control
• Analytical
• Microbiology
• Data Review