Senior Specialist, Field Quality jobs in United States
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Bristol Myers Squibb · 2 weeks ago

Senior Specialist, Field Quality

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. The Senior Specialist, Field Quality will provide quality assistance and oversight for operations, ensuring that manufactured products comply with applicable regulations and guidelines, while also performing batch production record reviews and supporting quality-related training and documentation.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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H1B Sponsor Likelynote

Responsibilities

Quality floor support of complex manufacturing activities
Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs
Perform walkthroughs of GMP areas documenting observations and areas of concern
Perform training on routine facility Quality tasks for new team members
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed
Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines
May support review of quality master data
Authors and revises QA specific SOPs and may provide QA review and approval of manufacturing related SOPs
May provide guidance to less experienced staff
Support the Quality approval of Master Batch Records or Syncade Recipes
Supports the Quality review and closure of no impact manufacturing deviations
May support release of incoming or manufactured products
Routine QA Floor Support Activities, including alarm review, logbook review, etc
Other duties as assigned

Qualification

CGMP regulations knowledgeBiotech manufacturing knowledgeBatch record reviewDeltaV system knowledgeSOP authoringTeam trainingQuality assurance supportInvestigation record generation

Required

A B.S. in science, engineering, biochemistry or related discipline, or its equivalent
A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality

Preferred

Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable
Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking, and maintenance is desirable

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
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
Up to 2 paid volunteer days per year
Annual Global Shutdown between Christmas and New Years Day.

Company

Bristol Myers Squibb

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At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

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 Company
Total Funding
$29.32B
Key Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B

Leadership Team

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Charles Bancroft
CFO
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Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
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Company data provided by crunchbase