Senior Specialist, QA Operations

Senior Specialist, QA Operations

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The 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 providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

Job Responsibilities

Essential 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 Quality disposition process by ensuring that 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.
• Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

Education and Experience

• BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
• Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Experience working in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other regulatory authorities is preferred.

Skills and Qualifications

• Expertise in GMP, Quality, material 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 applications in 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 operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

Work Environment

The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.