Senior Specialist, QC Compliance

Bristol Myers Squibb•Summit, NJ

2d•Hybrid

About The Position

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.

Requirements

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.
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.
Demonstrated experience with Quality management systems.
Demonstrated technical writing skills.
Demonstrated experience in laboratory or biomanufacturing.

Nice To Haves

Knowledge of cell therapy analytical and microbiological testing preferred.
Investigations and root cause analysis techniques preferred

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).

Benefits

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, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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