QA Shop Floor Specialist jobs in United States
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Bristol Myers Squibb · 2 hours ago

QA Shop Floor Specialist

Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines. The QA Shop Floor Specialist is responsible for quality oversight of Cell Therapy Development Operations activities, ensuring compliance with cGMP requirements and participating in quality check walkthroughs and documentation reviews.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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H1B Sponsor Likelynote

Responsibilities

Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
Participate in Shop Floor and Quality Check Walkthrough programs
Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations
Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints
Revise department SOPs, as well as Review and QA Approval of CTDO SOPs
Perform Real time review /approval of executed batch records and Chain of Identity verification
Responsible for ERP Material Status Changes of production/drug product
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements
Supports Risk Assessments/projects as required by senior management

Qualification

CGMP knowledgeQA functions experienceBatch record reviewSOP reviewProblem-solving skillsCommunication skillsOrganizational skillsInterpersonal skills

Required

BS/MS in a related scientific discipline
1-2 years of experience within QA functions in the pharmaceutical industry
Thorough knowledge of cGMP in the pharmaceutical industry
Good understanding of the drug development process
Knowledge and application experience with batch record review, product disposition/release, change control, SOP review, GMP inspection
Good computer skills and working knowledge of common business software
Excellent organizational skills
Excellent problem-solving, verbal, and written communication skills
Must have strong interpersonal and communication skills, be a team player
Must be an individual with proven initiative and demonstrated accountability
Professional integrity and maturity are required
Strong knowledge of cGMP Quality and Compliance principles required
Strong cross-functional collaboration experience required

Preferred

B.S. scientific discipline or relevant college / university degree preferred
Equivalent combination of education and experience acceptable
Clinical and Phase appropriate experience preferred

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