Quality Assurance Specialist
Grifols
full-time
Posted on:
Location Type: Hybrid
Location: RTP • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Supports and assesses activities to ensure adherence to quality and compliance processes
- Coordinates with donor centers for external inspections
- Aids with audit planning and responses
- Responsible for developing and reviewing audit responses / CAPA plans
- Ensures compliance with Domestic / European regulations through routine review
Requirements
- Bachelor’s Degree Required
- 5 years of experience
- Knowledge of the Code of Federal Regulations (CFR)
- Understanding of the European Pharmacopoeia (EP) and other European Guidelines
- Ability to write clear, concise, logical responses to regulatory authorities
- Strong interpersonal skills
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
audit planningCAPA plansregulatory compliance
Soft skills
interpersonal skillscommunication skills
Certifications
Bachelor’s Degree