Senior Specialist, QC Method Trending Lead
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us
Quality Control Method Trending Lead
To support QC methods and instrument performance by monitoring and analyzing invalid rates, using statistical tools, to monitor variation of reference standard data and critical reagents allowing for reaction to adverse trends within the QC Labs ensuring consistent performance.
- Monitor and analyze analytical method performance using statistical tools.
- Provide support during PMI/LES application maintenance related activities.
- Support data/analysis requests for APR/APQR, investigations, and analytical method changes within PMI and LES applications.
- Support optimization and improvements of analytical method performance data assessments and trending.
- Lead Manufacturing SPC QC evaluations.
- Lead QC MP-SAE evaluations.
- Support investigations related to release and method performance (OOT).
- Support data mining, collection, and verification to support local trending and network initiatives.
- Support or lead writing of technical reports, APQR, SAE Checklists and MPSAE Checklists.
- Participates in audit response development and management of response timeline and CAPA identification.
- Minimum BS degree with 4+ years relevant life-science industry experience (pharmaceutical/biologics) or statistics related subject preferably in a QC environment.
- Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic values of each. Knowledge and understanding of regulatory and technical data trending requirements and associated processes.
- Strong understanding/knowledge of Aegis (Discoverant), SAP, Sample Manager, LES, Empower and Infinity preferred.
- Ability to work collaboratively with all employees at all levels.
- Proficiency in Windows Server 2000, Windows 2003 Server, Oracle, SQL Server.
- Project management, problem-solving and decision-making skills.
- Ability to perform well in a team-based environment.
- Experience in choosing goals of significant projects or assignments.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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