Bristol-Myers Squibb

Specialist, Quality Assurance Drug Product Disposition

Bristol-Myers Squibb

Devens, MA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Bristol-Myers Squibb, we are committed to delivering innovative treatments to improve the lives of patients around the world. As a Specialist in Quality Assurance Drug Product Disposition, you will play a critical role in ensuring the safety and efficacy of our pharmaceutical products. You will be responsible for evaluating and approving the release of drug products for distribution, as well as investigating and resolving any quality issues. We are seeking a highly qualified candidate with a strong background in quality assurance and a deep understanding of drug product manufacturing processes. If you are passionate about making a positive impact on patients' lives and have the necessary skills and experience, we encourage you to apply for this exciting opportunity.

  1. Evaluate and approve the release of drug products for distribution, ensuring they meet all quality standards and regulatory requirements.
  2. Conduct thorough investigations of any quality issues related to drug products and provide timely resolution.
  3. Collaborate with cross-functional teams to ensure timely and efficient release of drug products.
  4. Develop and maintain a deep understanding of drug product manufacturing processes, including critical control points and quality assurance measures.
  5. Create and maintain standard operating procedures for quality assurance processes related to drug product disposition.
  6. Monitor and analyze data from quality control tests to identify trends and potential issues.
  7. Communicate with internal and external stakeholders, including regulatory agencies, regarding drug product quality and disposition.
  8. Participate in audits and inspections, providing necessary documentation and information to demonstrate compliance with regulations and standards.
  9. Stay updated on industry developments and regulatory changes related to drug product quality assurance.
  10. Train and mentor junior quality assurance team members to ensure consistency and high-quality performance.
  11. Identify and implement process improvements to increase efficiency and effectiveness of drug product disposition processes.
  12. Maintain accurate and thorough documentation of all quality assurance activities, including batch records, investigations, and audit reports.
  13. Adhere to all applicable laws, regulations, and Bristol-Myers Squibb policies and procedures.
  14. Represent Bristol-Myers Squibb as a knowledgeable and professional expert in drug product quality assurance in both internal and external settings.
Where is this job?
This job is located at Devens, MA, USA
Job Qualifications
  • Bachelor's Degree In Pharmaceutical Sciences, Chemistry, Or Related Field

  • Minimum Of 5 Years Experience In Quality Assurance Within The Pharmaceutical Industry

  • Strong Knowledge Of Regulatory Guidelines And Requirements, Including Fda, Ema, And Ich

  • Experience With Drug Product Disposition Activities Such As Batch Review And Release, Deviation Management, And Change Control

  • Excellent Communication And Problem-Solving Skills, With The Ability To Work Effectively In A Cross-Functional Team Environment.

Required Skills
  • Quality Assurance

  • Data Analysis

  • Product disposition

  • GMP Knowledge

  • Auditing

  • Quality Control

  • Root Cause Analysis

  • Compliance Management

  • Risk assessment

  • Regulatory Oversight

  • Batch Release

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Organization

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Specialist, Quality Assurance Drug Product Disposition in Devens, MA, USA is between $80,000 and $120,000 per year. This range can vary depending on factors such as the specific company, years of experience, and additional qualifications and certifications.

Additional Information
Bristol-Myers Squibb is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedDecember 20th, 2023
Apply BeforeMay 22nd, 2025
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About Bristol-Myers Squibb

Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.

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