Specialist, QA Deviation Reviewer and Approver

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 Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

Shift Available:

• Sunday - Wednesday, Onsite, 4 p.m. - 2 a.m.

Responsibilities:

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

• Review all data in accordance with applicable procedures and cGMP requirements.

• Anticipate and troubleshoot problems.  Communicate effectively with management regarding task completion, roadblocks, and needs.

• Support document revision, project, CAPA, and investigation/deviation related tasks.

• Perform assigned tasks within a CAPA, deviation, or project.

• Participate in projects and continuous improvement efforts.

• Perform other tasks as assigned.

• Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. 

• Ability to adapt to multiple changing priorities.

Knowledge & Skills:

• Must have knowledge and experience with US and global cGMP manufacturing, Quality, and Compliance.

• Understanding and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.

• Supports quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.

• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.

• Must provide guidance to other employees in the interpretation of technical/scientific issues.

• Must possess an independent mindset and tenacity.

Basic Requirements:

• Bachelor’s degree required, preferably in science-based field. 

• 1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience.

• 1-2 years of minimum within a manufacturing GMP environment.

• Good technical writing skill-set.

Preferred Requirements:

• Advanced degree, in a science area.

• Knowledge of LIMS and laboratory data analysis systems.