Quality Assurance Internship (Academic Credit)

Location: Los Angeles, CA, United States Department: Student/Intern/Trainee

Overview of Department & Mentor:

The Cedars-Sinai Biomanufacturing Center (CBC) is a 22,000 square-foot, state-of-the-art biomanufacturing facility that is comprised of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites, and process development rooms for producing the next-generation of cell and gene therapies. Lakshman Balajepalli is a senior Quality Assurance, Regulatory Affairs, and Quality Management Systems professional with more than 35 years of life sciences industry experience, including over 18 years in QA, QMS, regulatory compliance, manufacturing quality, validation, audits, and quality operations. He currently serves as Manager of Quality Assurance at the Cedars-Sinai Biomanufacturing Center, where he provides QA oversight for cGMP cell and gene therapy manufacturing, quality risk management, documentation practices, validation activities, clinical batch release, and regulatory audit support. His background spans cell and gene therapy, vaccines, in vitro diagnostics, molecular diagnostics, medical devices, and regulated manufacturing environments. As a mentor, he is well positioned to train interns in quality systems, GMP documentation, deviation/CAPA management, change control, audit readiness, validation principles, and cross-functional collaboration within a regulated biomanufacturing setting.

Role Activities & Timeline:

During month 1, the intern will complete onboarding, GMP orientation, safety training, documentation training, and an introduction to QA systems and internal procedures.

During months 2–3, the intern will assist with SOP and form routing, formatting, revision control, document archival, and digitalization of controlled documents.

During months 3–4, the intern will support deviation, CAPA, and change control activities, including logging records, tracking status, organizing supporting documentation, and helping monitor follow-up actions.

During months 4–5, the intern will assist with training record maintenance and quality data collection for metrics and trending.

During month 6, the intern will help summarize quality system activities, support reporting, and present key learnings to the QA team. T

hroughout the appointment, the intern will receive mentorship through regular check-ins, task-based training, feedback on documentation quality, and collaboration with QA, Manufacturing, QC, and Facilities teams.

Systems Access: Outlook, Teams, MS Office

Required Education & Experience:

Must be 18 years of age or older.

Must have a HS Diploma or GED.

Must reside in the greater Los Angeles area or surrounding cities while conducting all activities related to the intern appointment.

This internship is unpaid and must receive academic credit for the duration of the internship. The duration of this internship is January 2027 - June 2027.