Overview
Join the HJF Team!
HJF is seeking a
QA Specialist II
to provide raw materials, in-process, and final product inventory control according to Good Clinical Practice (GCP); to make continuous improvements to systems and processes to conduct, execute, and implement cGCP; and to increase efficiency. The second of four Quality Assurance individual contributor levels.
This position will be in support of translational and clinical research within the Defense Infectious Diseases Directorate (DIDD) at the Naval Medical Research Command (NMRC). The incumbent is tasked with supporting and conducting high-quality translational and clinical research to facilitate the development of infectious disease countermeasures for US military personnel. Within the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials. The NMRC CTC evaluates vaccines, therapeutics, prophylactics, and medical devices in human subjects to suitably advance innovative products from the laboratory to the front line and maximize the medical readiness of the Warfighter. This position will work within the NMRC CTC to support those clinical trial activities.
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic, and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities
Reviews and approves documents necessary for the conduct of human subjects' research to include epidemiologic research, FDA-regulated clinical trials, as well as clinical trials governed by other regulatory bodies. Develops and maintains a centralized documentation system for all records.
Conceives, develops, reviews, and maintains Standard Operating Procedures and other CTC-specific operational procedures.
Reviews and maintains Study-Specific Procedures and other protocol-related materials and/or documents and procedures and ensures study protocols are conducted in accordance with said procedures.
Documents and maintains documentation of all quality assurance processes.
Works with the CTC Director and other CTC personnel to identify and address any potential concerns regarding the conduct of a clinical trial, the quality of the data and/or results, and/or other CTC activities.
Coordinates all equipment/building validation issues and ensures regulatory compliance.
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.
Qualifications
Education and Experience
Associate's Degree is required; preferably in an area related to Life Sciences.
Minimum of 3-5 years' experience required.
Required Knowledge, Skills, and Abilities
Knowledge of FDA regulatory policies related to the conduct of clinical trials and handling of investigational products.
Excellent interpersonal and computer skills, including experience with MS Office products (MS Outlook, MS Excel, MS Word) and Adobe Professional.
Experience drafting and maintaining SOPs.
Ability to communicate effectively and to work with individuals of all levels.
Ability to handle multiple priorities, identify problems in real-time, and strong attention to detail.
Holds a valid driver's license.
Ability to obtain and maintain a T1/Public Trust background check.
Physical Capabilities
Lifting: Requires lifting materials up to 25 lbs.
Ability to stand or sit at a computer for prolonged periods.
Operating motor vehicles, machinery, and/or power tools.
Work Environment
This position will take place primarily in an office setting.
COVID-19 Vaccination Requirement
Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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