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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.
The Senior Specialist, QC Incoming will be responsible to ensure the technical capabilities for the QC Incoming testing laboratory. The QC Specialist, Incoming testing will support activities related to the Pharmacopeial compendial review, evaluates impact of compendial changes on applicable QC procedures and handles related change controls. In this role, you will also play a critical role in supporting method development and validations related to raw materials as well as supporting investigations and resolution of issues.
Skills/Knowledge Required
- CFC as Laboratory Technician or BS degree in Science, Chemistry, or equivalent.
- Advanced understanding of pharmaceutical regulatory requirements (cGMPs, JP, JPE, USP and Ph. Eur) and their impact to incoming material operations.
- Advanced understanding of technical capability of instrumentation, software and techniques used in Incoming testing.
- Experience of analytical testing according to Ph. Eur., JP and USP requirements.
- Experience in analytical method transfers and analytical method validation/verification.
- Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC) and wet chemistry techniques.
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
- Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
- Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments.
- Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
- Professional command of French and English, verbal and written. • Proven time management skills and a strong attention to detail.
- Proven analytical and problem-solving skills.
- Ability to work independently and compliantly.
Duties and Responsibilities
Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Maintains the GMP status of QC incoming operations:
- Establish incoming testing specification for the release of raw materials, Document rational for the establishment of testing
- Evaluates impact of compendial changes on applicable QC procedures and handles change controls as required
- Performs or supports feasibility experimental work as needed
- Lead and support method transfer, method verification and method validation activities, both internally and externally with contract testing laboratories.
- Writes analytical methods, verification protocols and reports, specifications, operating procedures. Ensure training of QC personal on incoming testing methods and procedures.
- Owns or support change controls related to incoming testing methods changes
- Leads or supports investigations in case of incoming testing-related deviations. Defines CAPA.
- Evaluate and process contract testing laboratories change notifications for impact to incoming materials
- Represents QC in cross-functional project teams supporting New Product Introductions, Material Qualification and Material Risk Assessment processes for excipients.
- Performs other tasks as assigned and project work
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.
On-site Protocol
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.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
