SummaryThe Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations Specialist will be responsible for providing oversight of shop floor activities in accordance with regulatory standards and RayzeBio procedures. The role will also support material and batch disposition activities.
This position will utilize Quality Assurance expertise to ensure compliance in operations supporting clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures, and global current Good Manufacturing Practices (cGMP).
The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This individual may also interact with the Qualified Person (QP), as needed, to facilitate release of EU doses.
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.- Build and maintain cross-functional relationships to improve processes and resolve issues.
- Provide Quality oversight on manufacturing and validation activities.
- Perform real-time review of manufacturing records.
- Perform periodic walkthroughs of Manufacturing and Quality Control areas to ensure continued compliance with procedures.
- Provide guidance on the handling of quality and shop floor activities.
- Support the Quality disposition process by ensuring all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
- Identify and report discrepancies from required work practices or procedures to management.
- Use AI tools to enhance individual productivity and quality of work.
- Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as needed.
- Participate, as requested, in response teams for audits and inspections by health authorities.
- Leverage AI tools to enhance individual productivity and quality of work.
Education & Experience- BS/MS degree in a science-related field preferred, including: Biology Biochemistry Chemistry Engineering Related scientific disciplines
- Minimum of 5 years of experience in Quality Assurance and/or Compliance roles within the pharmaceutical industry.
- Experience working in a GMP aseptic manufacturing environment preferred.
- Experience working with the FDA or other regulatory authorities preferred.
Skills & Qualifications- Expertise in GMP, Quality, material disposition, and product disposition.
- Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality Risk Management principles.
- Detail-oriented with demonstrated problem-solving and decision-making abilities with moderate oversight from management.
- Team player who can work independently to achieve objectives in a fast-paced environment.
- Excellent verbal and written communication skills.
- Strong background and demonstrated effectiveness in Quality Assurance operations and compliance supporting clinical and/or commercial manufacturing environments.
- Knowledge of U.S., EU, and global cGMP regulations and guidance.
- Knowledge of and experience working with FDA, EMA, or other regulatory authorities.
- Well-practiced in exercising sound judgment and decision-making.
- Demonstrated prioritization and organizational skills.
Physical Demands- Regularly required to sit, reach with hands and arms, and talk or hear.
- May occasionally lift and/or move up to 30 pounds.
- Must possess close and distance vision capabilities.
- Requires working in an environment with radioactive materials.
- Protective clothing, gloves, and safety glasses are required while performing duties in applicable areas.
Work Environment- Noise level in the work environment is usually moderate.
- This position may require work outside of normal business hours and occasional weekend support.
- Work is performed in a radiopharmaceutical manufacturing environment supporting clinical and commercial operations.
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We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Indianapolis - RayzeBio - IN: $82,236 - $99,650
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
