QC Compliance & Data Review Specialist III

R&D Partners is seeking to hire a QC Compliance & Data Review Specialist III in Frederick, MD.

Your main responsibilities as a QC Compliance & Data Review Specialist III:

· 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.

What we are looking for in a QC Compliance & Data Review Specialist III:

· 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.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

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

Pay Scale:

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

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.