Quality Systems Associate/Specialist

3 weeks ago

Indianapolis, United States RayzeBio Full time

Position: Quality Systems Associate/Specialist

Location: Indianapolis

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 (37NH)

The Quality Systems Associate/Specialist will help support the implementation and maintenance of the quality management system (QMS) for a new Radiopharmaceutical facility in Indianapolis, IN. The Quality Systems Associate/Specialist will be responsible for supporting QMS processes and software. The position will be a primary contact point for quality system support. This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate activities.

Job Responsibilities

  • Provide QA support and be a primary point of contact for quality systems and other operational systems.
  • Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.
  • Provide expertise and guidance in interpreting policies, regulatory guidelines, and regulations to ensure compliance.
  • Work in a GMP regulated environment to provide and assist in implementation of quality-related activities.
  • Coordinate and liaise with other departments to facilitate uniform quality standards for the site.
  • Ensure that compliance to the training program is maintained and updated as needed.

Education and Experience:

  • Associate: High School Degree or equivalent
  • 0-3 years of experience
  • Specialist: BS/MS in a Science related discipline preferred
  • 3-5 years of quality assurance experience
  • Pharmaceutical and GMP experience preferred
  • Experience working with FDA or other federal and state regulatory bodies

Skills and Qualifications:

  • 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

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