Quality Assurance Manager - NIH

Chenega Corporation•Bethesda, MD

2d•Onsite

About The Position

Come join a company that strives for Extraordinary People and Exceptional Performance! Chenega Services and Federal Solutions (CSFS) is seeking a Quality Assurance Specialist to provide support services to the National Institutes of Health (NIH) Clinical Center. Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities. We actively strive to channel our highly engaged employee’s knowledge, critical thinking, innovative solutions for our clients. Work Location: Onsite-9000 Rockville Pike Bethesda, Maryland 20892 United States

Requirements

Minimum of an B.S. degree in a related field.
Ability to read, write, and speak English well enough to effectively communicate with all parties.
Computer literate.
Possess sufficient initiative, interpersonal relationship skills and social sensitivity to enable relating constructively to a variety of patients from diverse backgrounds.

Responsibilities

Utilize knowledge of regulatory requirements and specifications for the oversight and monitoring of NIH intramural research facilities to ensure compliance with the Food and Drug Administration, United States Pharmacopeia, and NIH guidelines.
Participate in and collaborates with the Audit Program lead to support audits focused on Quality Management Systems, equipment/systems, facilities & utilities. Perform periodic review and maintenance of the current Audit Program, including data entry, KPI development and surveillance.
Provide knowledge on incident response processes and collaborates under a highly matrixed environment.
Support establishing processes, roles and responsibilities that contribute to the alignment of the Office’s strategic direction.
Perform investigations and provides corrective and preventive actions when excursions arise using risk-based methodologies.
Act as the Subject Matter Expert for various technical items, including, but not limited to Environmental Monitoring, and Validation/Qualification.
Support section programs that impact various departments/ICs such as Vendor Qualification activities.
Draft and review reports on an annual, quarterly and/or ad hoc basis; including risk/gap assessments and presentations.
Use project management tools and skills to develop appropriate metrics and prepares briefings for management/leadership.
Coordinate with various stakeholders, including the Hospital Engineering Facility Services, Facilities Compliance Inspection Branch and the Division of Facility Operation and Maintenance for inter-agency projects.
Other duties as assigned