Specialist, Quality Assurance Shop Floor

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 . At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor is responsible for quality activities supporting Manufacturing Operations in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing a real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. Must be available to work weekends and off shifts. Shifts Available: Sunday - Wednesday (every other Wed off), Onsite Evening Shift, 4 p.m. - 4:30 a.m. Responsibilities: Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements and resolve issues Perform QA shop floor activities, focused on Manufacturing Operations Ensure compliance with applicable procedures and production requirements Perform real-time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies Routinely recognizes and resolves Quality issues; Informs management of proposed solutions Seeks management guidance on complex issues Develops and revise procedures Knowledge & Skills: Must be action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking Understands continuous improvement and improves efficiency and productivity within the group or project Builds relationships internally within and with cross-functional teams. Contributes to goals within the workgroup Ability to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies Possess sound knowledge of FDA-regulated cGMP Quality Manufacturing operations and processes and global cGMP requirements Must be skilled in planning and organizing, decision-making, and building relationships Knowledge of quality processes, including material disposition, material storage, and handling requirements, change control, product complaints, deviations, investigations, and CAPA management Able to recognize conflict and notify management with proposed recommendations for resolution. Possess an independent mindset. Work is self-directed Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision Confident in making decisions for non-routine issue Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution Able to prepare written communications and communicate problems to management with clarity and accuracy Excellent verbal and written communication skills Basic Requirements: Associate degree. 1 year of experience working in a manufacturing GMP aseptic environment. 1 year of Quality Assurance experience within a cGMP environment. 1 year of deviation experience (to include strong technical writing). Available for weekend and off-shift hours. Preferred Requirements: Bachelor's Degree preferred. 3 years of cGMP Quality Manufacturing operations and processes work experience. Quality Assurance Shop Floor Manufacturing roles/experience highly desired (Ex. Quality Operations, In-process QA, IPQA, Quality Inspectors). Working Conditions: Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used. Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. 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: R1587018 Updated: 2024-11-22 06:14:31.042 UTC Location: Summit West-NJ 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.