Quality Assurance Specialist

Technical Resources International, Inc.; Bethesda (MD); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading contractor company in Bethesda is hiring a Quality Assurance Specialist to support the Quality Management System and maintain the QA training program. Responsibilities include managing audits of clinical sites and working with regulatory agencies. Ideal candidates should have a Bachelor's Degree and experience in Quality Systems for CROs. Join an equal opportunity employer committed to diversity in the workplace and enjoy a competitive salary in a dynamic environment.

Qualifications

• Bachelor's Degree in a relevant field.
• Experience in working with regulatory agency audits.
• Strong knowledge of GCP regulations.

Responsibilities

• Supports the maintenance and upkeep of the Quality Management System.
• Maintains the QA training program and document control.
• Supports audits of clinical sites and vendors.

Skills

Knowledge of current GCP regulations

Experience in working with regulatory agency audits

Experience in working with Quality Systems for CROs

Proficiency in MS Office

Education

Bachelor's Degree

Job description

Quality Assurance Specialist - (QAS001_COMPANY_1.1)

Job Title

Quality Assurance Specialist

Location

Bethesda, MD 20817 US (Primary)

Category

Quality Assurance

Job Type

Full-Time

Salary Range

$80,000-100,00/YEAR

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.
• 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.