Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: Indianapolis

NH#: 38

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Description

The Quality Assurance Specialist will help support operations through quality oversight in a new Radiopharmaceutical facility in Indianapolis, IN. The Quality Assurance Specialist will be responsible for providing oversight over shop floor activities which includes validation and manufacturing operations. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate activities.

Job Responsibilities

· Build and maintain cross functional relationships to improve processes and resolve issues.

· Provide quality oversight on manufacturing and validation activities.

· Ensure compliance with applicable procedural and protocol requirements.

· Perform real time review of manufacturing records.

· Perform periodic walkthroughs to ensure continued compliance with procedures.

· Ensure that compliance to the training program is maintained and updated as needed.

EDUCATION/EXPERIENCE/SKILLS

Education and Experience:

· BS/MS in a Science related discipline preferred

o 3-5 years of quality assurance experience

· Experience working in a GMP aseptic manufacturing environment preferred

· Experience working with FDA or other federal and state regulatory bodies

Skills:

· Highly motivated and organized professional with the ability to work independently

· Working knowledge of 21 CFR Parts 11, 210, and 211

· Very personable with strong communication skills

· Excellent professional ethics, integrity, and ability to maintain confidential information