Specialist, Quality Assurance Validation

Bristol Myers Squibb • New Brunswick, NJ

1d • Onsite

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.

Requirements

• 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

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees