The Senior Scientist, Quality Control Compliance Microbiology will work both independently and with the team overseeing all of the QC analytical related compliance records across Deviations, CAPA’s and Change Control. This role will be primarily responsible for providing technical assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis driven investigational testing plans. In addition, this role will work closely with the Lab Excellence team on areas for improvements. This position is part of the Summit Quality Control Compliance Team, which is composed of two pillars: Compliance and Continuous Improvement. While this is a site-based role, collaboration across other sites in the CTDO network and the BMS Global network is essential.
What You Will Do
- Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures(cGMP), USP, EU and other global regulatory requirements at all times.
- Follow directions properly, work cooperatively as an individual contributor and as a team member.
- Communicate effectively with QC peers, cross-functional peers and management.
- Must have strong analytical technical skills to provide assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis driven investigational testing plans.
- Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
- Knowledge of problem-solving methods used to perform Root Cause Analysis
- Support investigations and CAPAs associated with QC Department.
Experience
- Requires Bachelor’s degree in Molecular Biology, Chemistry, or related discipline.
- Minimum 5 years of experience working in a regulated manufacturing environment.
- An equivalent combination of experience/education is acceptable
At Bristol Myers Squibb, we’re inspired by this single, powerful vision. Passionate and precise, we bring life-saving medicines to people around the world. And we work together with compassion to improve outcomes for the patients who need us most.
We are a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. Innovative science is our passion. Transformational medicines are our goal. Bristol Myers Squibb is committed to discovering, developing, and delivering transformational medicines in areas where we believe we have an opportunity to make a meaningful difference for patients: oncology, immunoscience, cardiovascular, and fibrosis.
We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
Bristol-Myers Squibb gives you the opportunity to learn and grow professionally alongside smart, creative, and talented colleagues who are committed to helping patients battle serious diseases. Doing amazing things with people you like and admire isn’t something you can find just anywhere.
Our mission to enhance the lives of our patients requires an investment in a strong learning culture. By providing valuable learning opportunities, connecting you to your passion, and helping you achieve your personal aspirations, we are empowering you to make a difference.
This includes:
- Digital Learning
- Developmental Programs
- Leadership & Management Programs
- Insights for Success
- General Manager Development
- Building Manager Capability
- Coaching & Mentoring
