Quality Assurance Specialist I - FDA

Chenega Corporation - Silver Spring, MD (30+ days ago)3.7


Chenega Professional & Technical Services (CPTS) is seeking a Quality Assurance Specialist I to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE).

Essential Duties and Responsibilities: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
Support in the development of a quality management system for OSE’s process and procedural documents. Establish a method for storing, retrieving, updating and version control for all process and procedure documents in the system.
Develop a process document that explains the process for storing, retrieving and updating documents in the system.
Perform testing of the quality management system to ensure its functionality and usability for the end user.
Identifies issues with the system and develops solutions to solve each issue.
Assess the current and future needs of the office and provides recommendations for the system.

Non-Essential Duties:
Other duties as assigned.

Supervisory Responsibilities:
None.

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Bachelor’s degree in a health-related field and at least 4 years of experience in the public health field.
At least 2 years of experience in developing, testing, and maintaining document repository systems.

Knowledge, Skills and Abilities:
Strong working knowledge of Microsoft Office.
Strong organization and communication skills.

Diversity:
Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.

Ethics:
Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.
During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.

Chenega Corporation and family of companies is an EOE.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program.
M#
Qualifications

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Bachelor’s degree in a health-related field and at least 4 years of experience in the public health field.
At least 2 years of experience in developing, testing, and maintaining document repository systems.

Job Quality Assurance
Primary LocationUnited States-Maryland-Silver Spring
Organization Chenega Professional & Technical Services
Recruiter Mary Jacenich