Quality Assurance Specialist
Company: Medical Science
Posted on: June 21, 2022
We are currently searching for a Quality Assurance Specialist to
provide support to the National Institutes of Health (NIH). This
opportunity is a full-time position with MSC and it is onsite in
Duties & Responsibilities
* Support the development, implementation, maintenance, and
oversite of a clinical quality management system.
* Facilitate working groups to collaborate and write
project-controlled documents as part of the quality management
system: SOPs, Policies, Audit reports, etc.
* Support the development and implementation of the Division's
electronic Clinical Quality Management System (Master Control).
* Stay current with changes to current GCP/GCLP regulations,
including FDA, EU, and other regulatory bodies and guidance
* Lead internal and external audits of the various quality elements
to ensure compliance to GCP/GCLP, industry best practices and
* Participate in oversight and management of Investigator Site
Audits, Internal Audit and Clinical Vendors/CROs Quality Programs
with guidance from management.
* Support the development and/or review of GCP/GCLP audit agendas,
audit plans, audit reports, and CAPA's for internal & external
* Participate in preparations for regulatory inspections, which may
include reviewing Inspection Readiness Plans, Mock Inspections, and
risk-based management of program inspection quality events.
* Assist in resolving compliance issues at clinical sites, clinical
vendors, and laboratories; and provide assessment of the impact of
* Review, track and/or trends routine quality data.
* Report adverse trends to management with remediation plan.
* Coordinate the development of various QA related metric
* Bachelor's degree in a related discipline.
* Minimum of five (5) years of experience in clinical research or a
* Experience in establishing and managing quality management
systems for clinical research (e.g. in pharmaceutical companies,
biotechnology companies, CRO, or government sponsors).
* Working knowledge of the quality management cycle (i.e., PDCA),
and corrective Action/Prevention Action (CAPA) processes.
* Experience with US and international Good Clinical Practice
(GCP), Good Clinical Laboratory Practice (GCLP) regulations,
guidance documents, and industry best practice in all areas of a
* Knowledge of electronic clinical quality management systems (such
as Veeva, Master Control, etc.) is preferred.
* Experience in regulatory inspections from the US FDA or similar
government regulatory authorities is preferred.
* Experience conducting or overseeing audits is preferred.
* Experience working at a clinical research site is preferred.
* Experience in the NIH or other government agency is
* General skills:
* Excellent communication skills both verbally and written; and
across functions internally and externally.
* The ability to organize, prioritize and deliver tasks & projects
according to pre-defined deliverables.
* The ability to effectively build and maintain relationships with
multiple departments and external entities (e.g., Investigator
sites, clinical Vendors/CROs) in order to effectively solve
problems o Excellent multi-tasking, analytical, organizational and
* Ability to troubleshoot, identify root cause and systematically
* Produces high-quality work on complex problems with
* Proficient in Window based software to include Excel, Word.
Dovel Technologies and its Family of Companies (Medical Science &
Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to
the public sector and commercial markets, with broad capabilities
in management, technology, and risk consulting. By combining our
public and private sector expertise, we help clients address their
most complex challenges and navigate significant regulatory
pressures focusing on transformational change, business resiliency,
and technology-driven innovation. Across a range of advisory,
consulting, outsourcing, and digital services, we create scalable,
innovative solutions that help our clients outwit complexity and
position them for future growth and success. The company has more
than 12,000 professionals in over 50 locations globally. Guidehouse
is a Veritas Capital portfolio company, led by seasoned
professionals with proven and diverse expertise in traditional and
emerging technologies, markets, and agenda-setting issues driving
national and global economies.
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employer. All qualified applicants will receive consideration for
employment without regard to race, color, national origin,
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Keywords: Medical Science, Rockville , Quality Assurance Specialist, Other , Rockville, Maryland
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