Quality Assurance/Regulatory Affairs Intern

Company: Rallybio, LLC
Role:Quality Assurance/Regulatory Affairs Intern (Paid)
Internship Period: June 2021-August 2021
Location: Remote-Based or In-person (if conditions permit)
Reports to: Quality & Regulatory Lead

Rallybio, is a privately held development-stage biotechnology company incorporated in January 2018.  The Company has raised more than $180 million in financing with the ambition to transform the lives of patients with devastating diseases and has a pipeline of assets in development.

Rallybio is looking for a Quality Assurance/Regulatory Affairs Intern to support Quality and Regulatory Affairs operational activities.  Responsibilities will include performing activities associated with the preparation and rollout of an enterprise-wide, cloud-based Quality Management System, facilitation of electronic tools to support regulatory submissions and accelerate the integration of program related materials within the chosen electronic document management system for Rallybio.

The internship candidate should be available for 10 weeks of the internship (approximately June 2021 – August 2022) on a part time basis. The position can be performed remotely and optional in office experience may be obtained depending on the status of the COVID-19 pandemic as permitted under local and state guidelines as well as company-specific guidelines during the internship period.

Essential Duties & Responsibilities:

The Quality Assurance/Reg Affairs Internship position provides an opportunity for a student currently pursuing a degree in STEM to get hands on experience working within Quality Assurance/ Regulatory Affairs role within a dynamic biotech. The successful candidate must have strong self‑motivation, the ability to work both independently and within a team environment. Strong follow up, organization and prioritization skills, and excellent attention to detail are a must.     Your contributions include (but are not limited to):  Supporting a range of activities, including document control, quality assurance, regulatory operations and document change processesProcuring and implementing electronic library accessible to all Rallybio colleague in support of regulatory submissionsOrganizing existing data and records to facilitate data migration and implementation of an electronic document management Collecting, organizing, and creating project files  Identifying and facilitating creation of document types required to migrate QA documentation to electronic system. Scanning, uploading and organizing documents and records Creating training materials, as requiredInteracting with various colleagues and disciplines within the company  

Skills, Experience and Qualifications

  • Enrolled in a Bachelor of Arts/Science degree in Biotechnology, Biology, Chemistry, Process Engineering, or other Life Sciences.
  • Proficiency in MS office suite and cloud-based document sharing tools
  • Ability to develop innovative/creative solutions to issues
  • Good verbal and written communication skills
  • Ability to think creatively and be a team player
  • Offer flexibility with a willingness to work on multiple projects simultaneously

Qualified candidates should submit their resume to HR@rallybio.com.  This role is open for direct candidate submission and no recruiters will be used.

Rallybio is proud to be an Equal Employment Opportunity and Affirmative Action employer.  We celebrate diversity and are committed to creating an inclusive environment for all employees.  All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.  We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.