À propos
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). 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 person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses. 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 or a related 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. 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. Compensation Overview: Indianapolis - RayzeBio - IN: $82,236 - $99,650 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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 a supportive culture, promoting global participation 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 an 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
Compétences linguistiques
- English
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