732-661-0400

QA R&D Specialist

  • Location: Columbus, OH
  • Type: Contract
  • Job #37768

Job Description

  • The Consultant, Research & Clinical Development QA, Nonclinical Quality will be responsible for providing assistance to the Quality Assurance Unit in their oversight of the general Quality Systems and nonclinical studies conducted at Sarepta, OH GTCOE site.  Additional assistance in support of quality oversight of clinical assays and assay validations is also included. This position will liaise with the Genetic Therapies Center of Excellence (GTCOE) personnel, as well as other Sarepta groups in an effort to ensure a high level of quality and consistency across the Sarepta platform; assist the GLP/GCLP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance. This position will participate in inspection readiness activities and audits, as appropriate.  This position will report to the Director/Associate Director, Nonclinical Quality, Research & Clinical Development Quality Assurance (R&CD QA). 

     

     

     

    Primary Responsibilities Include:

    • Perform, monitor and document internal phase audits associated with facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations
    • Review of study protocols and final reports
    • Review of the controlled documents associated with the site GLP activities (i.e. SOPs, protocols, laboratory notebooks, etc.)
    • Review of facility, equipment and utility program, software and/or application associated with the GLP site.  Review and document non-conformances
    • Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics.
    • Review of any change control activities related to the site
    • Support GLP/GCLP regulatory inspection activities at Sarepta OH site

     

     

     

    Desired Education and Skills:

     

    • BS/BA Degree in a scientific discipline. Advanced degree preferred.
    • 5+ years experience in a related industry
    • 2+ years in a Quality Assurance role.
    • Technical knowledge of preclinical/clinical laboratory operations and animal facility operations.
    • Excellent organizational skills; ability to work independently and in team environments;
    • Demonstrated understanding of FDA and Global GLP/GCP/GCLP requirements and guidance documents, ability to apply to day to day operations.
    • Familiarity with Good Documentation Practices
    • Experience working with document control systems and electronics QMS preferred
    • Experience with Corrective and Preventive Action, Investigation /Deviation writing and reviewing
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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