Quality Assurance Specilaist (GCP and CRO experience required)

Industry

Health and Safety

Advert ID

USA_450138

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD60000-90000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

QUALITY ASSURANCE SPECIALIST (GCP & CRO experience required) (3 positions)



* Verifying clinical compliance to applicable Standard Operating Procedures (SOPs) and applicable regulations.

* Conducting internal audits.

* Preparing and reviewing Project Specific Procedures.

* Training staff in supporting the Quality Management System.

* Supporting hosting of client audits.

* Conducting external audits at clinical sites and vendor sites; reviewing clinical quality management plans

* Leading process improvement activities and CAPA investigations.



REQUIREMENTS

* Minimum a BS/BA

* Certification as a Quality Auditor (e.g. CQA) preferred.

* Two (2) to five (5) years of progressive QA experience, preferably in a CRO environment.

* Solid understanding and working knowledge of GCP (minimum 5 years).

* Experience working with Quality Management Systems.

* Proficiency in MS Office.

* Travel up to 25%.