GCLP Quality Assurance Specialist

Did you know that our client has impacted the lives of thousands of people around the world through cutting-edge advancements in translational research, biomedical informatics, and data science applications?  

A bioscience and information technology company is seeking a GCLP Quality Assurance Specialis to join their vibrant team join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP)

Responsibilities

• Develop and implement quality control reporting systems.
• Serve as the subject matter expert for GCLP and GLP compliance-related inquiries from both internal and external stakeholders.
• Perform internal inspections to ensure compliance with GCLP standards on a regular (e.g. during testing, monthly, or quarterly basis as required).
• Provide assistance in the SOP management.
• Maintain all master document inventories, program schedules, training files, word documents, and drafts with the Federal Task Leader and relevant GCLP staff.
• Perform or delegate laboratory equipment control documentation and schedule necessary/routine preventative maintenance.
• Review study documentation with management to ensure completeness and ensure proper archival of trial-related materials.
• Maintain archives with proper disposal of documents according to record retention guidelines.
• Prepare appropriate documentation and respond to requests for GCLP inspections and internal/external audits.
• Provide support to management in preparing, tracking, and responding to deviations and CAPA.
• Provide guidance and recommendations for development and improvement of the quality assurance and archival programs.
• Adjust quickly to changes in schedule as priorities shift.
• Wear appropriate Personal Protective Equipment (PPE) when in BSL-2 laboratories.
• Work collaboratively with team members to ensure necessary information is cataloged, digitized, and archived at the end of a study.
• Sustain close and effective communications with VIP management and external collaborators.

Experience Required / Requirements

• BS with 5+ years of experience in a GCLP environment, working with quality assurance.
• IT skills such that candidate knows or can quickly learn to utilize LIMS, CQMS, ELN, Microsoft Office, etc.
• Ability to work well with others and independently.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
 

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