
Specialist, Quality Assurance Drug Product Disposition
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.
- Evaluate and approve the release of drug products for distribution, ensuring they meet all quality standards and regulatory requirements.
- Conduct thorough investigations of any quality issues related to drug products and provide timely resolution.
- Collaborate with cross-functional teams to ensure timely and efficient release of drug products.
- Develop and maintain a deep understanding of drug product manufacturing processes, including critical control points and quality assurance measures.
- Create and maintain standard operating procedures for quality assurance processes related to drug product disposition.
- Monitor and analyze data from quality control tests to identify trends and potential issues.
- Communicate with internal and external stakeholders, including regulatory agencies, regarding drug product quality and disposition.
- Participate in audits and inspections, providing necessary documentation and information to demonstrate compliance with regulations and standards.
- Stay updated on industry developments and regulatory changes related to drug product quality assurance.
- Train and mentor junior quality assurance team members to ensure consistency and high-quality performance.
- Identify and implement process improvements to increase efficiency and effectiveness of drug product disposition processes.
- Maintain accurate and thorough documentation of all quality assurance activities, including batch records, investigations, and audit reports.
- Adhere to all applicable laws, regulations, and Bristol-Myers Squibb policies and procedures.
- Represent Bristol-Myers Squibb as a knowledgeable and professional expert in drug product quality assurance in both internal and external settings.
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.
Quality Assurance
Data Analysis
Product disposition
GMP Knowledge
Auditing
Quality Control
Root Cause Analysis
Compliance Management
Risk assessment
Regulatory Oversight
Batch Release
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
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.
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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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