Bristol Myers Squibb · 6 hours ago
Specialist, Quality Assurance Validation
New Brunswick - NJ - US
Full-time
Onsite
Mid Level
$79K/yr - $96K/yr
3+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. They are seeking a Specialist in Quality Assurance Validation to perform independent reviews and approvals of quality lifecycle documents and provide guidance on quality issues during regulatory inspections.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
Master of Science or a Bachelor of Science with 3-5 years' experience, including 1-3 years' experience in regulated function
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: Process control systems, Process equipment & utilities, Laboratory equipment & instrumentation, Packaging & Labelling equipment, Environmental monitoring systems, Supply Chain systems
Effective interpersonal and organizational skills
Demonstrated leadership skills
Proficiency with MS Office Suite
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.
Paid Time Off
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-18
2026-01-16
Company data provided by crunchbase