Specialist, Shop Floor Quality Assurance, Cell Therapy

Full Time
Devens, MA 01434
Posted
Job description

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

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.

This role will require shift and/or weekend work. The following shifts are available: Overnight; 6pm - 6am

Job Responsibilities:

  • 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.

Physical 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.

#BMSCART, #Veteran, #LI-Onsite, #NIGHT_SHIFT_QUALITY

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

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 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.

smogtown13.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, smogtown13.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, smogtown13.com is the ideal place to find your next job.

Intrested in this job?

Related Jobs

All Related Listed jobs