GLP Quality Assurance Specialist I - Armed Forces Radiobiology Research Institute

Join the HJF Team!

HJF is seeking a GLP Quality Assurance Specialist I to support the Research Support Group (RSG) within the Armed Forces Radiobiology Research Institute (AFRRI) in Bethesda, MD. HJF provides scientific, technical and programmatic support services to RSG.

The Good Laboratory Practice (GLP) Quality Assurance Specialist I is a member of the GLP Quality Assurance Unit supporting the Armed Forces Radiobiology Research Institute.  This position is responsible to ensure compliance in all aspects of the Institute’s developing GLP program in accordance with 21 CFR 58.35 and Institute standard operation procedures (SOPs). 

Responsibilities:

1. Assist in providing program-wide guidance in the development of GLP compliant administrative, operational, and technical procedures and working practices.  Review a wide variety of standard operating procedures (SOPs) and other regulated documents for GLP compliance. (25%)
2. Plan and provide program-wide quality control review of facility documents, procedures, and deviations; assist staff in planning corrective actions and ensure that corrective actions are completed. (25%)
3. Assist with planning and conducting study, facility, and process-based quality assurance audits for compliance to standard operating procedures (SOP) and the GLP regulations. Prepare written audit reports.  Participate in and assist with sponsor, FDA, or other external GLP audits. Assist in drafting external audit responses. (20%)
4. Guide and educate administrative and technical staff in meeting GLP compliance. Assist in developing, planning and conducting GLP compliance training. (15%)
5. Participate in the development, implementation, and maintenance of Quality Assurance program and SOPs. (10%)
6. Maintain up to date knowledge of applicable regulations and industry standards. Facilitate the implementation of any regulatory or best practice changes into the Institute’s program. (5%)
7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities: Knowledge of GLP and associated regulations, direct experience/knowledge of GLP Quality Assurance and animal-based research. Ability to coordinate and follow through on multiple complex assignments concurrently; ability to meet multiple deadlines; ability to draft/review regulated documents and analyze study data; ability to collaborate with all levels of staff and management; ability to provide guidance with diplomacy and tact.  Must be proactive and able to work independently; must possess excellent oral and written communication skills as well as superior interpersonal skills; must be well organized. 

Minimum Education: Bachelor’s degree is required. Direct experience in GLP Quality Assurance and/or direct experience in animal-based research may be substituted for educational and certification requirements.

Minimum Experience/ Training Requirements: 0-2 years of relevant work experience required.

Required Licenses, Certification or Registration: Certification as RQAP in GLP.

Work Environment: Set in an office work environment.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check. 

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.