Senior Specialist, Quality Assurance
Welcome to Bristol-Myers Squibb, a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines to patients in need. We are seeking a highly skilled and experienced Senior Specialist, Quality Assurance to join our team. As a Senior Specialist, you will play a critical role in ensuring the quality and compliance of our products through the implementation of robust quality systems. Your expertise and attention to detail will be essential in supporting our mission of improving patients' lives. If you have a passion for quality and a strong background in pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.
- Develop and implement quality assurance policies and procedures in accordance with industry standards and regulations.
- Conduct audits and reviews of manufacturing processes, documentation, and facilities to ensure compliance with quality standards.
- Collaborate with cross-functional teams to identify and resolve quality-related issues and implement corrective and preventive actions.
- Evaluate and approve changes to manufacturing processes, equipment, and materials to ensure they meet quality requirements.
- Review batch records and other documentation to ensure accuracy, completeness, and compliance with regulations.
- Develop and maintain quality metrics to monitor and improve product quality and compliance.
- Provide training and guidance to team members on quality procedures and best practices.
- Stay current with industry regulations and guidelines, and proactively identify and implement necessary updates to quality systems.
- Participate in regulatory inspections and provide support for quality-related inquiries.
- Communicate effectively with internal and external stakeholders to ensure timely resolution of quality issues.
- Lead or participate in quality improvement projects to enhance product quality and compliance.
- Maintain accurate and up-to-date documentation and records related to quality activities.
- Mentor and provide guidance to junior quality assurance staff.
- Uphold the company's mission and values, and promote a culture of quality and continuous improvement.
Excellent Communication And Interpersonal Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And External Stakeholders.
Minimum Of 8 Years Experience In Quality Assurance Within The Pharmaceutical Industry.
In-Depth Knowledge Of Fda And International Regulatory Requirements For Pharmaceutical Manufacturing And Quality Control.
Demonstrated Leadership Skills And Experience Managing A Team In A Quality Assurance Role.
Strong Understanding Of Quality Systems, Including Risk Management, Deviation Management, And Change Control Processes.
Process Improvement
Data Analysis
GMP Knowledge
Quality Systems
Auditing
Quality Control
Team Leadership
Compliance Management
Risk assessment
SOP Development
Regulatory Standards
ROOT
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Specialist, Quality Assurance in Summit, NJ, USA is between $80,000 and $110,000 per year. This can vary depending on factors such as experience, education, and the specific company and industry.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
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.
Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started