GLP Associate

Updated: January 3, 2019
Job ID: 214383
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a GLP Associate to support the Good Laboratory Practice Program within The Armed Forces Radiobiology Research Institute (AFRRI) located in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to AFRRI. 

The incumbent will act as the GLP Equipment Manager, assist with SOP administration, and participate in data/review and maintenance. 

Responsibilities: 

  1. Independently act as the GLP Equipment Manager including maintaining equipment maintenance logs and reviewing equipment SOPs.  Work with equipment owners/users, vendors, and service providers to ensure that equipment is maintained and used in compliance with the SOPs.  Review all GLP equipment records for SOP and GLP compliance.
  2. Manage equipment validation projects and validated system change control incidents including drafting validation and change control documents and assisting with risk assessments. Work with consultants, vendors, equipment owners/users, information technology, and the GLP team to ensure that equipment has been validated for GLP use. 
  3. When assigned, provide support to or take the lead in SOP administration activities such as providing paper and electronic SOP document control, completing SOP distribution, and tracking completion of SOP reading. 
  4. Contribute to the GLP program development and maintenance by working with GLP management, team members, and Quality Assurance to: develop, implement and/or review a variety of GLP compliant SOPs; provide guidance to Institutional staff in matters relating to GLP and SOP compliance; provide quality control review of a wide variety of study, procedural, and facility records for SOP, protocol, and GLP compliance; assist in deviation reports and resolutions; facilitate GLP data and record management and archival.    
  5. Maintain assigned GLP program components in an audit ready state and respond to auditor requests and audit reports as assigned.  
  6. Perform other duties as assigned

Required Knowledge, Skills, and Abilities:  Knowledge of Good Laboratory Practice Regulations, familiarity with Word and Excel, strong written and verbal communication skills, excellent organization skills

Minimum Education/training:  Bachelor’s degree in a scientific discipline or a related field

Minimum Experience: At least 2 years of experience working in a GLP environment and at least one year in GXP equipment management. 

Physical Requirements:  Ability to sit or stand for long periods of time.  A health screen for measles titer and TB required. 

Work Environment:  Office environment, with some non-technical work in laboratories and the animal facility. 

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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