Research & Clinical Development QA

4 weeks ago

Columbus, United States ApTask Full time

About Client:
The Client is a biotechnology company that focuses on the development of precision genetic medicines for the treatment of rare neuromuscular diseases. It primarily focuses on developing therapies for rare neuromuscular diseases, particularly those caused by genetic mutations. Their main focus is on Duchenne muscular dystrophy (DMD), a severe muscle-wasting disease that primarily affects young boys.
It works closely with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to obtain approvals for its therapies. They conduct clinical trials to demonstrate the safety and efficacy of their products in patients.

Rate Range: $50-$55/Hr

Job Description:

  • The Consultant, Research & Clinical Development QA, Nonclinical Quality will be responsible for providing assistance to the Quality Assurance Unit in their GLP 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 client groups in an effort to ensure a high level of quality and consistency across the client 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, Nonclinical Quality, Research & Clinical Development Quality Assurance (R&CD QA).
Primary Responsibilities Include:
  • Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs.
  • Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations.
  • Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management.
  • Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics.
  • Support internal, Sponsor or regulatory inspection activities at the Sarepta OH site
Desired Education and Skills:
  • BS/BA Degree in a scientific discipline. Advanced degree preferred.
  • 5+ years experience in a related regulated industry
  • 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role.
  • Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations
  • 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 reviewing Corrective and Preventive Actions, Laboratory Investigations and Deviations preferred.



About ApTask:
Join ApTask, a global leader in workforce solutions and talent acquisition services, as we shape the future of work. We offer a comprehensive suite of offerings, including staffing and recruitment services, managed services, IT consulting, and project management, providing unparalleled opportunities for professional growth and development. As a member of our dynamic team, you'll have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success for our clients across diverse industries. If you are passionate about excellence, collaboration, and innovation, and aspire to make a meaningful impact in the world of work, come join us at ApTask and be a part of our mission to empower organizations to thrive.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

If you have any concerns or queries about your personal information, please feel free to contact our compliance team at .
 

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