Quality Assurance/Quality Control Associate

Updated: February 12, 2018
Job ID: 213640
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a Quality Assurance/Quality Control Associate to support the Armed Forces Radiobiology Research Institute (AFRRI), a tri-service biomedical research laboratory and a major component of the Uniformed Services University of the Health Sciences (USU) located in Bethesda, Maryland. AFRRI conducts research in the field of radiobiology and related matters essential to the operational and medical support of the U.S. Department of Defense and the military services. HJF provides scientific, technical and programmatic support services to AFRRI and USU.

The Quality Assurance / Quality Control (QA/QC) Associate will assist with all aspects of compliance associated with the Institute’s growing Good Laboratory Practice (GLP) program. Associate will also participate as a member of the Quality Assurance Unit (QAU) as well as assist in GLP program development, maintenance, and quality control.

Responsibilities:

  1. As assigned, participate as a member the GLP QAU in accordance            90% effort with FDA regulations, 21 CFR 58.35, and AFRRI SOPs.  In coordination with the GLP QAU manager:
    1. Plan and conduct facility and process audits.
    2. Assist in study based audits such as critical phase inspections, raw data audits, report audits, and protocol audits for GLP studies and activities.  Assist with external audits.
    3. Prepare written reports of audits and distribute reports to the appropriate persons.
    4. Develop, implement, and maintain QA standard operating procedures (SOPs).
    5. Assist in preparing GLP QA statements to be included in final study reports.
    6. Assist in ensuring that all quality based deliverables comply with regulatory and quality policies and procedures and that timelines are met.
    7. Provide guidance and/or participate in the development of administrative, operational, and scientific GLP SOPs and working practices.  Review SOPs for GLP compliance.
  2. Work closely with GLP management, administrative, and scientific/operations staff to assist in developing and maintaining GLP compliance; assist in finding flexible or non-standard options for meeting compliance requirements.
    1. Plan and conduct GLP compliance training. 
    2. Assist in maintaining/developing the GLP administrative program arm.
    3. Provide program wide quality control review of documents, procedures (may include laboratory animals) and deviations; assist staff in planning corrective actions and ensuring that corrective actions are completed.
    4. When assigned, provide study coordination for GLP and GLP-like studies
  3. Perform other duties as assigned                                                                    

Job Specifications:

Required Knowledge, Skills, and Abilities:

  • Thorough understanding of FDA GLP regulations
  • Conversant in biological, medical, and chemistry related scientific terminology
  • Excellent interpersonal, facilitation, presentation and communication skills with demonstrable flexibility, tact and diplomacy
  • Ability to function in a team environment
  • Excellent organizational skills
  • Ability to plan and complete tasks independently
  • Travel may be necessary

Minimum Education/training:  BS in scientific discipline; Certification by the Society of Quality Assurance as a Registered Quality Assurance Professional in GLP or similar is preferred

Minimum Experience:  2-4 years of experience in GLP or other quality management system, with at least 1 year direct experience in quality assurance.  Additional laboratory or operational experience preferred.

Physical Requirements:  Ability to sit or stand for long periods of time.  Must comply with the Institute’s occupational health and safety requirements and be able to perform work while wearing personal protective equipment (PPE) when needed.

Supervisory Responsibilities/Controls:  N/A 

Work Environment:  Office environment with some inspection duties in laboratories, the animal facility, and other functional areas. 

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

HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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