Document Control Specialist

Join the HJF Team!

HJF is seeking a Document Control Specialist who will provide support to the quality group and manage documents. Makes continuous improvements to inventory systems that executes and implements GMPs while increasing system efficiency.

This position will be in support of the Diagnostics and Countermeasures Branch. The Document Control Specialist is responsible for managing documents for the Quality Group in support of the Diagnostics and Countermeasures Branch (DCB) within the Center of Infectious Disease Research (CIDR) at the Walter Reed Army Institute of Research (WRAIR). The incumbent will work with a team of Quality Assurance and Quality Control (QA/QC) specialists and laboratory personnel to ensure all documents meet and exceed the highest U.S regulatory agency and accrediting body standards to include the College of American Pathologists (CAP), Department of Defense (DoD) Clinical Laboratory Improvement Program (CLIP), Clinical Laboratory Improvement Amendments (CLIA), Good Clinical Laboratory Practices (GCLP) and U.S. FDA requirements. Document management will include development, ensuring proper completion by technical staff based on Good Documentation Practices and as required by CAP and DCB Policies and Procedures.

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.

Note: This site requires that non U.S. Citizens reside in the United States for three of the five recent years.

• Supports the Quality Assurance Manager to ensure CAP/CLIA/FDA regulatory compliance in all aspects of laboratory documentation and quality products/deliverables.
• Performs Sub-Administrator tasks in MasterControl and will serve as a super user within the Quality team to manage all standard operating procedures and policies within MasterControl.
• Works with the Quality Group to help prepare all binders and quality documents for bi-annual CAP inspections of DCB's two CAP-accredited laboratories.
• Performs document reviews, revisions, and ensures DCB documents are accurate, version controlled, and adhere to DCB's quality standards, Good Documentation Practices, and procedure.
• Creates and manages a Quality Inventory Log of all paper and electronic documents and performs a monthly audit to ensure they remain current and up to date and provides Audit Reports to the QA Manager and Senior Project Manager - QI.
• Serves as a liaison between the Quality Group and Group Leads to assist in reviewing or assisting in drafting documents (early stages) to meet DCB's quality standards including formatting, ensuring documents are clear, concise, and accurate.
• Assists the QA Group to train DCB staff in the appropriate use and preparation of controlled documents within DCB.
• Manages the CLSI documents and other standards to ensure the standards (inventory log) remain up to date to use as a resource for DCB staff.
• Provides notifications via email to DCB Leadership and Group Leads as Standard Operating Procedures and/or Policies, CLSI standards or others are released, rejected, or archived.
• Assists the QA group in conducting internal audits of various sections within DCB including preparing and updating relevant binders and generating Audit Reports
• Other duties as assigned.

Education and Experience

• Vocational or technical training or degree required. Bachelor's degree preferred within life Science.
• Minimum of 0-2 years experience required.

Required Knowledge, Skills and Abilities

• Experience working with MasterControl, Q-pulse or other Quality Document Management/Control system is preferred.
• Excellent verbal and written communication skills.
• Excellent organizational skills, has great attention to detail and interpersonal skills.
• Ability to work independently once trained and able to maintain excellent records.
• Proficient computer skills and knowledge of Macintosh and PC related software such as Microsoft Office Suite or related software.
• Experience working in a regulated environment, with knowledge of GCLP and CAP/CLIA/FDA requirements is preferred.
• Ability to handle multiple priorities.
• Ability to obtain and maintain a T1/Public Trust background check.

Work Environment

• This position will take place primarily in an office setting.

Compensation

• The hourly pay range for this position is $24.09 - $26.45. Actual hourly pay will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

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.