Quality Assurance Specialist, Audit and Compliance
Grifols
full-time
Posted on:
Location Type: Hybrid
Location: RTP • North Carolina • United States
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About the role
- Supports and assesses activities that ensure organizational adherence to corporate quality and compliance processes
- Coordinates with donor centers and shared services with external inspections
- Aids with audit planning, audit responses, and Plasma Master File (PMF) updates
- Prepares Site Master Files (SMFs) for external EMA inspections
- Represents organization during inspections by Regulatory Authorities
- Develops, writes, and reviews external and internal audit responses
Requirements
- Bachelor’s Degree Required
- 5 years of experience
- Understanding of the Code of Federal Regulations (CFR)
- Knowledge of the European Pharmacopoeia (EP) and other European Guidelines
- Strong interpersonal skills
- Ability to communicate effectively with diverse groups
Benefits
- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
audit planningaudit responsesPlasma Master File (PMF) updatesSite Master Files (SMFs)Regulatory Authority inspections
Soft Skills
interpersonal skillscommunication skills
Certifications
Bachelor’s Degree