Quality Assurance Specialist

Company: Medical Science
Location: Rockville
Posted on: June 21, 2022

Job Description:

Overview

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 Rockville, MD.

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 bodies.
* Lead internal and external audits of the various quality elements to ensure compliance to GCP/GCLP, industry best practices and guidance.
* 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 audits.
* 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 any deficiencies.
* Review, track and/or trends routine quality data.
* Report adverse trends to management with remediation plan.
* Coordinate the development of various QA related metric reports.

Requirements

* Bachelor's degree in a related discipline.
* Minimum of five (5) years of experience in clinical research or a related field.
* 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 GxP environment.
* 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 preferred.
* 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 teamwork skills.
* Ability to troubleshoot, identify root cause and systematically resolve problems.
* Produces high-quality work on complex problems with cross-functional involvement.
* Proficient in Window based software to include Excel, Word.



Company Description

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.

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

Keywords: Medical Science, Rockville , Quality Assurance Specialist, Other , Rockville, Maryland