Senior Specialist, Quality Control

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.

PURPOSE AND SCOPE OF POSITION:

The primary focus of the Quality Control Specialist role to support product lot release and in-process testing within a cGMP environment. This includes the ability in interface with multiply groups, provide technical support and troubleshooting, and when needed provide support for training and method transfers.   

DUTIES AND RESPONSIBILITIES:

• Perform testing and data review of in-process, final product, and stability samples of cell therapy product in accordance with appliable procedures and cGMP requirements. 
• Ensure timely completion of testing and tasks as assigned. 
• Capable of handling complex issues, solving problems and troubleshoot with minimal guidance. 
• Author and revise technical documents such as test methods, SOPs, specifications, and/or sample plans as appropriate. 
• Support method transfers, method validation, and new instrument implementation by representing site QC in cross-site protocols reviews and approval. 
• Own and lead Deviation, CAPA, Laboratory Investigations, and Change Controls. 
• Train and mentor others on Quality Control test methods and processes. 
• Champion and foster a positive and successful collaborative quality culture. 
• Lead the design, implementation and continuous improvement projects for Quality Control systems and processes that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. 
• Perform other tasks as assigned.

REQUIREMENTS:

• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects with little supervision.
• Experience with cell-based assay and flow cytometry, preferred.
• Computer proficiency as well as strong scientific and organizational skills.
• Experience working in in a regulated (GxP) environment and familiarity with various Quality Systems, preferred.
• Demonstrated success working in a high-performing, business results-driven environment.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Ability to maintain flexible intellect and adjust to a dynamic work environment.

This is a Wed - Sat AM Shift (6am - 4:30pm)

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or higher degree in scientific discipline.
• 4+ years of analytical QC testing within a regulated environment, or equivalent combination of education and experience.
• Experience working in a regulated (GxP) environment and familiarity with various Quality Systems.

• Technical background and experience in cell and molecular biology techniques such as cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique is preferred.
  • Demonstrated success working in a high-performing, business results-driven environment.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.