Good Clinical Laboratory Practice (GCLP) Specialist

This job posting is no longer active

Updated: January 23, 2019
Job ID: 214474
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Good Clinical Laboratory Practice (GCLP) Specialist to support the Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences in Bethesda, MD. HJF provides scientific, technical and programmatic support services to SC2i. 

The incumbent will ensure SC2i laboratory operations conducted at both the Uniformed Services University and the Walter Reed National Military Medical Center remain compliant with approved procedures. 

Responsibilities: 

  1. Responsible for monitoring compliance of the SC2i Quality Management Plan (QMP) and quality policies at USU – WR Surgery.
  2. Assist in the development, revision, and dissemination of laboratory procedures consistent with industry best practices.
  3. Standard Operating Procedure development and implementation.
  4. Support the development and monitoring of laboratory activities conducted under specific FDA sponsored trials. 
  5. Provide expert advice and contribute to the development and implementation of laboratory-related policies.
  6. Evaluate compliance plan effectiveness.
  7. Review and update Compliance policies and procedures as necessary.
  8. Identify areas of compliance vulnerability; develop, implement, and monitor appropriate corrective and preventive actions (CAPAs).
  9. Work with upper level management to develop an effective consortium training plan.
  10. Serve as a technical resource to the research team, including assay validation activities.
  11. Perform other assignments as required.

Required Knowledge, Skills, and Abilities: Broad experience in clinical research management, clinical trials, and cellular molecular biology. Competency in setting and maintaining quality standards aligned with US FDA GLP, CLIA/CAP, and other applicable international GLP regulations and GCLP guidance. Additionally working knowledge of standards such as, but not limited to, 9001, 13485, 17025, 14971, 21CFR820, 21CFR11, 45CFR46 and the ICH guidelines Outstanding English writing skills; ability to independently draft unique correspondence, SOPs, reports and presentations. Ability to work independently once a task is assigned; ability to prioritize and manage workload effectively; ability to multi-task effectively; ability to function effectively as part of a team. Working knowledge of Microsoft Office applications, including PowerPoint, Word, Excel and Outlook. Ability to identify and research problems/issues thoroughly and use discerning judgment in problem solving for organization, management, and scientific issues using a significant degree of qualitative, quantitative and analytical skill.

Minimum Education/Training Requirements: Masters in a biological or related science.

Minimum Experience: 2-4 years expertise directly related to regulatory and clinical laboratory compliance activities.

Physical Capabilities: Bending, standing, and sitting

Work Environment: Office environment.

Background: US Citizenship required; eligibility to obtain and hold Department of Defense issued Secret Clearance.

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.

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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