Specialist, Quality Assurance Validation

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.

Key Responsibilities

• Perform independent review and approval of initial Commissioning, Qualification, and Validation (CQV) lifecycle documents and subsequent changes.
• Review and approval of periodic reviews, re-qualification, decommissioning and retirement and plans, protocols, and summary reports.
• Review and approval of Standard Operating Procedures, Work Instructions, Deviations, CAPAs and Change Controls related to facilities, utilities, equipment, instruments, and systems.
• Provide instruction and guidance on CQV quality issues during regulatory agency inspections, deviations, and CAPA discussions.
• Support the Contract Service Providers program.
• Provide reports to management related to timely deviation completions, CAPA implementations or other issues related to CQV and CSV activities.
• Support Product Development and Product Development Quality initiatives as needed.
• Bring to the attention of management, any information relating to the impact of policies, procedures, and industry quality regulations on quality systems.

Requirements

Qualifications & Experience • Master of Science or a Bachelor of Science with 3-5 years’ experience, including

1-3 years’ experience in regulated function careers.bms.com

-Experience as a CQV, QA, and/or QC representative within Pharmaceutical/Drug Substance Manufacturing (API, Sterile, Non-Sterile or Biological products) or Medical Device Manufacturing or Laboratory environment

• Demonstrated knowledge and experience in cGMP regulations

• Working knowledge in the following: o Process control systems o Process equipment & utilities o Laboratory equipment & instrumentation o Packaging & Labelling equipment o Environmental monitoring systems o Supply Chain systems

• Effective interpersonal and organizational skills • Demonstrated leadership skills

• Proficiency with MS Office Suite

#LI-ONSITE

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:

New Brunswick - NJ - US: $78,980 - $95,708

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 https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, busi