QA Manufacturing Operations Senior Specialist

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 . • ** 12 HR SHIFT 5am-5pm. - rotating schedule*** KNOWLEDGE AND SKILLS REQUIRED: • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. • A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality preferred. • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. • Knowledge of US and EU cGMP regulations and guidance. • Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable. MAJOR DUTIES AND RESONSIBILITIES • Quality floor support of complex manufacturing activities • Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. • Perform walkthroughs of GMP areas documenting observations and areas of concern. • Perform training on routine facility Quality tasks for new team members. • Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. • Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. • May support review of quality master data. • Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs. • May provide guidance to less experienced staff. • Support the Quality approval of Master Batch Records or Syncade Recipes. • Supports the Quality review and closure of no impact manufacturing deviations. • May support release of incoming or manufactured products. • Routine QA Floor Support Activities, including alarm review, logbook review, etc. • Other duties as assigned. CONTACT: • Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff, as they conduct record reviews and respond to events occurring during day to day operations. WORKING CONDITIONS: • Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals. Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment. #BMSBLIf 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/ 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations