Senior Specialist, QC Analytical
About the role
Position summary
Key Responsibilities
- Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
- Anticipate and perform troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review and review of GMP documentation for general and complex methods. Perform QC disposition of the SOTR.
- Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- Train and mentor others on QC test methods, GMP processes and procedures.
- Perform other tasks as required to support the QC laboratories.
Specific Knowledge, Skills, Abilities
:
- Ability to accurately and completely understand, follow, interpret and apply BMS Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- Advanced knowledge of LIMS, Document Management and Quality Management and laboratory data analysis systems preferred.
- High problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
Education/Experience/ Licenses/Certifications
:
- Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred.
- NL: Master's or Bachelor's degree /HLO in (bioanalytical) science required.
- 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience in cell and molecular biology techniques (e.g. HPLC/UPLC assays, cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
#LI-Hybrid
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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Who can apply
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