Quality Assurance Specialist

Location

Bethesda, MD 20817 US (Primary)

Category

Quality Assurance

Job Type

Full-Time

Salary Range

$70,000-$85,000

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.

Job Requirements

• 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.
• Travel up to 15% (domestic and international)
• This role is fully remote for those living in the DMV area.

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.