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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Quality Assurance Associate 2 - Shop Floor, Cell Therapy

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeDevens, MA, USAIn-person

About the Job

Requirements

  • Ability to understand, follow, and apply approved procedures.
  • Basic computer skills, including knowledge of Microsoft Office.
  • Ability to understand problems and propose practical solutions.
  • Ability to communicate effectively with cross-functional peers and direct management in writing and verbally.
  • Ability to work in a fast-paced team environment with changing priorities.
  • Detail orientation and task focus, with the ability to meet deadlines and prioritize assigned work.
  • Ability to recognize when issues need to be escalated.
  • High school diploma or associate degree with an equivalent combination of education and work experience may be considered.
  • 0–2 years of relevant current Good Manufacturing Practice (cGMP) experience.
  • Awareness of workplace hazards, including pressurized liquids and gases, steam, and hazardous chemicals; personal protective equipment and cleanroom gowning are required in applicable facility areas.

Responsibilities

  • Provide on-the-floor quality oversight to Manufacturing, Quality Control, and Supply Chain Operations, respond to minor issues, and escalate issues to senior team members as needed.
  • Perform and document operational verification according to approved procedures.
  • Observe manufacturing operations and identify departures from cleanroom behaviors and aseptic techniques.
  • Provide quality oversight to maintenance operations and support pre-approved return-to-service plans.
  • Conduct area walkthroughs to identify quality issues and support remediation to ensure the floor and operations adhere to cGMP and approved procedures.
  • Review manufacturing or testing records for compliance with approved procedures, communicate and resolve discrepancies, and escalate as required.
  • Identify improvement opportunities and support execution of site and team continuous-improvement goals and projects.
  • Maintain compliance with the assigned learning plan.
  • Support internal and external inspections as required.
  • Contribute to discrepancy assessments and initiate quality events.
  • Participate in cross-departmental and cross-functional meetings, communicate professionally, and share data and knowledge within the team.
  • Build relationships within the direct team and partner functions.

Desired Qualifications

  • A bachelor's degree in a STEM field is preferred.
  • Experience with FDA or EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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