Intern, Clinical Quality Assurance
Mirum Pharmaceuticals Inc.
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
As an Intern within Mirum’s Clinical Quality Assurance (CQA) Department, you will work closely with the CQA team to support the implementation of GCP quality processes (i.e., audits and deviations) into Veeva system and the maintenance of other working shared drive used for clinical QA. This entry-level position provides an excellent opportunity to gain practical and hands-on experience in the use to common quality systems and Good Clinical Practice (GCP), which is a high demand knowledge in new drug development, while contributing to the overall success of the organization.
- This will be a 8-week assignment, 40 hours/week, paid internship
- Housing costs will not be reimbursed.
- Required to be on-site in Foster City, CA
RESPONSIBILITIES AND MAIN TASKS
- Complete training on Veeva QMS and relevant SOPs/Processes
- Support CQA management team to investigate gaps within Veeva QMS for GCP audit process
- Support CQA management team to implement the enhanced clinical vendor deviation process within Veeva QDOC system and provide process guidance to clinical teams upon request
- Manage the weekly CQA department meetings including taking and maintaining meeting minutes
- Support the CQA team to maintain GCP tracking tools and provide metrics/data upon request
- Organize and maintain CQA files and databases, ensuring accuracy and completeness
- Assist in enhancing working instructions, job aides and other relevant documents related to GCP QA processes
- Provide appropriate support to the CQA team as deemed needed.
REQUIREMENTS
Minimum Requirements
- Undergraduate or Graduate student in a scientific or related discipline.
- Extensive knowledge of MicroSoft Office applications
Required Skills
- Passion to learn
- Ability to adopt urgent situations and accept ad hoc assignments
- Demonstrated ability to prioritize tasks and meet deadlines.
- Organized, responsible, resourceful, and detail-oriented
- Strong written and oral communication skills
- Ability to work effectively both independently and within a team.
Benefits For You
- Gain meaningful professional experience in the field of Clinical Quality Systems
- Gain cross-functional insight learning how to work within a global company
- Working in a friendly environment with a collaborative spirit
- Given an opportunity to improve personal growth and development
Please include your cover letter with your application describing your qualifications and reasoning for wanting this internship. The pay for this role will be in the $35-45/hr range.
#LI-ONSITE
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.