Senior Specialist, QC Compliance

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. 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.

Position Summary

Responsible for leading QC deviation, laboratory investigations, CAPAs and change control. May provide support during health agency inspection

 

Shift Available:

• Tuesday- Saturday, Hybrid Evening Shift 3:00 p.m. to 11:30 p.m.

 

Duties/Responsibilities:

• Lead and author QC deviation, laboratory investigations, CAPAs and change control.

• Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.

• Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts.

• Train and mentor others on deviation, investigation, CAPA and change control process/ procedures.

• May support health agency inspection as equipment area subject matter expert.

• Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).

 

Knowledge & Skills:

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.

• High problem-solving ability/mentality, critical thinking, technically adept and logical.

• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.

• Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work..

 

Education/Experience:

• Bachelor’s degree in science, engineering, or related discipline.

• 4+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.

• Knowledge of cell therapy analytical and microbiological testing preferred.

• Demonstrated experience with Quality management systems.

• Demonstrated technical writing skills.

• Demonstrated experience in laboratory or biomanufacturing.

• Investigations and root cause analysis techniques preferred

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.

Compensation Overview:

Summit West - NJ - US: $83,670 - $101,393

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit