Quality Assurance Specialist
2 weeks ago
Job Title
Quality Assurance Specialist
Location
Bethesda, MD 20817 US (Primary)
Category
Quality Assurance
Job Type
Full-Time
Education
Bachelor's Degree
Travel
Up to 25%
Job Description
- Supports the maintenance and upkeep of the Quality Management System.
- Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.
- Supports audits of clinical sites and vendors/suppliers.
- Supports internal audit program and performance metrics system for continual improvement.
- Manages the review cycle of QA controlled documents to assure practices reflect written procedures.
- Supports regulatory agency audits.
- Knowledge of current GCP regulations.
- Experience in working with regulatory agency audits.
- Experience in working with Quality Systems for CROs.
- Excellent written/verbal communication skills.
- Proficiency in MS Office.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
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