Description
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.
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