Clinical Quality Assurance Specialist
Company: The Emmes Company, LLC
Location: Rockville
Posted on: February 24, 2021
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Job Description:
The Emmes Company, LLC is seeking a Clinical Quality Assurance
Specialist based out of our Rockville, MD, Frederick, MD, or
Tysons, VA offices to support all phases of clinical trials. Emmes
provides flexibility for the office location or work remote
preference dependent upon position. The Emmes Company, LLC
established in 1977, is a Contract Research Organization (CRO).
Headquartered in Rockville, Maryland, Emmes employs over six
hundred staff worldwide with offices located in Frederick,
Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore,
India. Ranked as a top area workplace of choice by the Washington
Post, Emmes fosters an environment of collaboration, professional
growth, and exceptional work life balance. Our studies impact
public health initiatives on a global scale occurring in more than
sixty countries spanning across six continents. We are dedicated to
providing statistical and epidemiological expertise, computer
systems deployment, data management, study monitoring, regulatory
guidance, and overall operational support to clients engaged in
biomedical research. Emmes offers support for the entire process of
clinical trials from study design and protocol development through
data analysis and manuscript generation. Emmes is seeking a QA
Specialist in our Rockville or Frederick, MD, offices to support
all phases of clinical trials. Primary Purpose The QA Specialist
will assist in the management of overall quality, compliance, and
auditing activities to ensure compliance of operations with
corporate policies, industry standards, and applicable regulations
by conducting audits of Emmes projects, department, processes, and
vendors used to support clinical trials. He/she will be responsible
for assisting in various quality improvement initiatives in order
to comply with Good Clinical Practice (GCP) and ICH requirements,
SOPs, and applicable regulations. This individual will work closely
with a Quality Assurance Manager in support of Emmes' corporate
Quality Assurance Department. Primary Responsibilities * Conduct
internal audits to identify non-compliance in adherence to SOPs and
regulations * Provide GCP/QA consultation to Emmes staff * Support
regulatory/client audits * Support supplier/vendor qualification
and evaluation * Support / lead quality and standardization
initiatives * Drive completion of quality compliance plans *
Write/revise SOPs, as needed * Prepare Quality Management Reports *
Support quality improvement initiatives in order to comply with
Good Clinical Practice (GCP) requirements, SOPs, applicable
regulations, and promote quality Requirements * BS degree and 2
years GxP industry experience * Experience with GxP auditing
activities * Certified Quality Auditor (ASQ-CQA, RQAP-GCP), ISO,
CCRA, or equivalent certification recommended * Knowledge of
ICH-GCP and appropriate regional clinical research regulations and
guidelines preferred * Strong written and oral communication skills
* Ability to work with others as well as independently * Ability to
multi-task * Excellent organizational and time management skills *
Enjoy working in a team environment * Required Travel: Up to 25% to
conduct supplier/vendor audits * Remote staff may be required to
work from the Rockville, MD location to support third party
regulatory inspections and client audits CONNECT WITH US!! Follow
us on Twitter - @EmmesCRO Find us on LinkedIn - The Emmes Company,
LLC The Emmes Company, LLC is an equal opportunity affirmative
action employer and does not discriminate in its selection and
employment practices. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, political affiliation, sexual
orientation, gender identity, marital status, disability, protected
veteran status, genetic information, age, or other legally
protected characteristics.
Keywords: The Emmes Company, LLC, Rockville , Clinical Quality Assurance Specialist, Healthcare , Rockville, Maryland
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