Specialist, Quality Assurance 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 rich in diversity. 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. Read more: careers.bms.com/working-with-us . 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. Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required in a multi-phase and commercial radiopharmaceutical facility. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. This is an onsite position at Rayzebio's Indianapolis, IN site Key Responsibilities: Quality floor support of complex manufacturing activities, including line release, alarm review, logbook review, etc. Gowning is required when working in ISO classified spaces. Build and maintain cross functional relationships to improve processes, resolve issues, and facilitate uniform quality standards Performs walkthroughs of GMP areas documenting observations and areas of concern Performs training on routine facility Quality tasks for new team members Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs Assures all electronic and paper documentation, which requires QA review is in compliance with site procedures and protocols, cGMP regulations, and other industry guidelines Authors and revises Quality-specific SOPs and may provide Quality review and approval of manufacturing related SOPs Supports the Quality review and closure of manufacturing deviations, corrective and preventative actions, and change controls, including evaluation of root cause analyses, as well as impact and risk assessments Supports the Quality review and closure of Out-of-Specification results and Lab Events identified during Quality Control testing of raw materials and manufactured drug products Supports release of incoming raw materials Other duties as assigned No travel required Education and Experience: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred, advance degree a plus. A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality preferred. Knowledge of late phase and commercial GMP aseptic manufacturing, analytical and Microbial testing is highly desirable. Knowledge of US and EU cGMP regulations. Knowledge of electronic or paper batch record systems and other electronic systems applicable to laboratory test result generation, investigations, inventory management, and equipment tracking and maintenance is desirable. ASQ or ISO certification a plus/ Skills and Qualifications: Highly motivated and organized professional with the ability to work independently Working knowledge of 21 CFR Parts 11, 210, 211 and EU regulations Personable with strong communication skills and ability to multi-task Excellent professional ethics, integrity, and ability to maintain confidential information 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 a laboratory and ISO classified environments with radioactive materials, where protective clothing, gloves, and safety glasses may be required. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Company: Bristol-Myers Squibb Req Number: R1587550 Updated: 2024-11-19 02:34:35.251 UTC Location: Indianapolis-IN Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.