QA Senior Specialist

Are you a detail-oriented individual with a passion for ensuring quality in all aspects of pharmaceutical development? Do you thrive in a fast-paced and dynamic environment where your critical thinking skills and attention to detail are valued? Bristol-Myers Squibb is seeking a Senior QA Specialist to join our team and play a vital role in ensuring the safety, efficacy, and regulatory compliance of our innovative medicines. As a Senior QA Specialist, you will have the opportunity to work with cross-functional teams and utilize your expertise to drive continuous improvement in our quality systems. If you are a self-starter with a strong understanding of quality principles and regulations, we encourage you to apply for this exciting opportunity.

1. Develop and implement quality assurance strategies and processes to ensure compliance with regulatory standards and industry best practices.
2. Conduct thorough reviews and evaluations of pharmaceutical development processes, procedures, and documentation to identify areas for improvement and recommend solutions.
3. Collaborate with cross-functional teams to ensure quality standards are met throughout the entire pharmaceutical development lifecycle.
4. Utilize critical thinking and problem-solving skills to troubleshoot and resolve quality issues as they arise.
5. Develop and maintain quality metrics to monitor and improve the effectiveness and efficiency of quality processes.
6. Provide guidance and training to team members on quality principles, regulations, and standard operating procedures.
7. Conduct audits of internal processes and external suppliers to ensure compliance with company policies and regulatory requirements.
8. Stay up-to-date on industry trends, changes in regulations, and best practices to continuously improve quality systems.
9. Lead or participate in quality improvement projects to drive continuous improvement and enhance overall quality performance.
10. Communicate effectively with stakeholders at all levels to ensure understanding and alignment of quality standards and objectives.
11. Review and approve documentation related to pharmaceutical development, including protocols, reports, and batch records.
12. Ensure timely resolution of quality issues and support the timely release of products to market.
13. Participate in regulatory inspections and support the preparation of necessary documentation.
14. Foster a culture of quality and compliance throughout the organization.
15. Mentor and train junior team members to promote professional growth and development.

According to JobzMall, the average salary range for a QA Senior Specialist in Summit, NJ, USA is $80,000 to $110,000 per year. However, this may vary depending on the specific company, experience level, and other factors. It is recommended to research the specific company and job requirements for a more accurate salary estimate.

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.