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.
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
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
Akebia Therapeutics, Inc.