Full-Time

Specialist

QA Shop Floor

Posted on 4/17/2025

Bristol Myers Squibb

Bristol Myers Squibb

10,001+ employees

Develops and delivers biopharmaceutical medicines

No salary listed

Mid

Company Historically Provides H1B Sponsorship

Summit, NJ, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Must be able to work in the cleanroom environment for 6-hour time periods.
  • Must be available for weekend and off-shift hours.
  • Must be flexible for shift hour changes to support manufacturing.
  • Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Must possess an independent mindset.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
  • Develops procedures.
  • Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with cross functional teams.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.
Responsibilities
  • Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities make improvements and resolve issues.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.
  • Issue production batch records and product labels to Operations.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Desired Qualifications
  • Bachelor’s degree. An equivalent combination of education and experience may be considered.
  • 3 years of Quality Assurance.
  • 1-year prior deviation experience/knowledge.
  • Strong computers skills.
  • Aseptic experience preferred.

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, particularly in oncology, immunology, and cardiovascular health. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs that are affordable alternatives to their innovative medicines, ensuring they meet high quality and safety standards. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, as well as its commitment to sustainability and corporate responsibility. The company's goal is to improve patient outcomes by providing effective and affordable healthcare solutions while adhering to Environmental, Social, and Governance (ESG) principles.

Company Size

10,001+

Company Stage

IPO

Headquarters

New York City, New York

Founded

1887

Simplify Jobs

Simplify's Take

What believers are saying

  • AI-driven drug discovery accelerates BMS's R&D, improving drug development efficiency.
  • BMS's acquisition of 2seventy bio enhances its cancer cell therapy capabilities.
  • Positive Phase 3 trial results for Sotyktu boost BMS's psoriatic arthritis treatment portfolio.

What critics are saying

  • Increased competition in oncology may impact BMS's market share.
  • Layoffs could decrease employee morale, affecting operational efficiency.
  • Integration challenges from acquiring 2seventy bio may pose financial risks.

What makes Bristol Myers Squibb unique

  • BMS focuses on oncology, immunology, and cardiovascular diseases, setting it apart in biopharma.
  • The company integrates AI in early lung cancer diagnosis, enhancing precision care.
  • BMS offers both innovative and generic medicines, increasing healthcare accessibility.

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Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Company News

European HHHM
Apr 16th, 2025
Optellum Announces Agreement with Bristol Myers Squibb to Leverage AI to Boost Early Lung Cancer Diagnosis

Optellum, a global leader in AI-driven clinical decision support for early lung cancer diagnosis, has entered an agreement with Bristol Myers Squibb (NYSE: BMY), to leverage AI in early diagnosis and precision lung cancer care.

CMMB
Mar 24th, 2025
Our Values, Your Impact

In partnership with Bristol Myers Squibb, Catholic Medical Mission Board Inc. is playing a role in building the infrastructure and workforce to bring quality cancer care to rural Kenya.

PR Newswire
Mar 20th, 2025
Bristol Myers Squibb Appoints Osama Braiwish As General Manager For Saudi Arabia Gulf Countries

RIYADH, Saudi Arabia, March 20, 2025 /PRNewswire/ -- Bristol Myers Squibb, a leading global biopharmaceutical company, has recently appointed Osama Braiwish as its General Manager for Saudi Arabia and Gulf Countries, an affiliate covering Saudi Arabia, United Arab Emirates, Kuwait, Qatar, Oman, Bahrain, and Jordan

Investors Hangout
Mar 20th, 2025
Bristol Myers Squibb Welcomes New Leadership in Gulf Region

Bristol Myers Squibb, a leader in the global biopharmaceutical sector, has appointed Osama Braiwish as its General Manager for the Gulf region, thereby enhancing its capacity to serve medical needs across various specialties.

Business Wire
Mar 12th, 2025
2seventy bio Enters into Definitive Agreement to be Acquired by Bristol Myers Squibb

2seventy bio, Inc. (Nasdaq: TSVT), today announced a definitive merger agreement under which Bristol Myers Squibb (NYSE: BMY) (“BMS”) will acquire all

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