Specialist, Shop Floor Quality Assurance, Cell Therapy, Day Shift (6am-6pm)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
Bristol-Myers Squibb is seeking a Shop Floor (Field) QA Specialist for the QA Operations organization at the Cell Therapy Facility in Devens, MA. As our Field QA Specialist, you will be responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
Perform QA shop floor activities.
Ensure manufacturing compliance with applicable procedures and batch records.
Perform real time review of manufacturing batch records.
Review manufacturing shop floor documentation.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
Qualifications and Education Requirements:
High School Degree required.
Relevant college or university degree preferred.
Minimum 2 years relevant work experience, with experience in a Quality Assurance role.
Equivalent combination of education and experience acceptable.
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.
Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
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.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Must 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 issues.
Develops and revises procedures.
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.
Able to effectively multi-task.
Knowledge of US and global cGMP requirements.
Able to lift up-to 25 pounds several times a day.
Able to stand and walk for several hours at a time in a 12-hour shift.
Able to move between rooms in a timely manner.
Able to work near strong magnetic fields.
Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
#LI-Onsite #BMSCART #VETERAN
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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