Quality Assurance Intern (91-10)

Akebia Therapeutics, Inc. Cambridge , MA 02138

Posted 4 months ago

Akebia is seeking a summer intern to work with the Quality team. The individual will have the opportunity to explore the role of Quality in drug development including current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), and current Good Clinical and Pharmacovigilance Practices (cGCP, cGPV). This is anticipated to be a 12-week internship and located in our Cambridge, MA offices.

As part of Quality, this position will have the chance to interact with many of the other functions in the company expanding the opportunity to learn about different facets of the pharmaceutical industry.

Required Skills

  • Review audit reports and track flow of information and follow-up

  • Participate in the review and QC of data and/or reports generated from various departments

  • Assist with the maintenance of record keeping

  • Help with the tracking of key timelines and milestones

  • Perform related duties as requested

  • Assist with Regulatory Inspection Readiness activities

  • Prepare commonly requested documents for easy retrieval (Org charts, SOP logs, etc)

  • Potentially support back room inspection activities

  • Catalog and organize electronic records from our suppliers

  • Catalog and organize SOP files and historical training records

Required Experience

  • Currently enrolled in a B.S. or M.S. program at an accredited university and in good academic standing

  • Must have completed at least two years of college education prior to beginning the internship

  • Interested in learning more about the role of Quality in the drug development process

  • Sound working knowledge in Microsoft Office

  • Interest in learning about rules and regulations that govern quality compliance in drug development

  • Willing to take direction from various Quality team members

  • Effective communication skills with detailed focus and eager to learn

  • Must be available to work 32 to 40 hours per week for approximately 12 weeks during the summer

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

Job Location Cambridge, Massachusetts, United States Position Type Full-Time/Regular

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Quality Assurance Intern (91-10)

Akebia Therapeutics, Inc.