Quality Assurance Specialist

Location
Bethesda, MD
Posted
Jan 03, 2019
Required Education
Bachelors Degree
Position Type
Full time

Founded in 1979, Technical Resources International, Inc. (TRI) is a full-service contract research organization plus (CRO+) providing product development support services to the global drug, biologic, and medical device community through the effective combination of scientific, clinical information technology, and communications services. TRI, Inc. is currently seeking a Quality Assurance Specialist to join our Bethesda team.

Responsible for verifying clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations by performing internal audits.  Promotes Quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System. Responsibilities may also include hosting client audits, conducting external audits at clinical sites and vendor sites, reviewing clinical quality management plans, leading process improvement activities and leading CAPA investigations.  

Minimum a BS/BA, Certified Quality Auditor preferred.  5-8 years of progressive QA experience, preferably in a CRO environment.  A solid understanding and working knowledge of GCP (minimum 5 years).  Experience working with Quality Management Systems. Proficiency in MS Office.  Travel up to 15%.

Submit resume with salary requirements to Attn: SL, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-7412, or email to HR@tech-res.com.

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.