QC Analytical Specialist — Data Review & Method Validation

Bristol Myers Squibb EU Policy; Leiden; On-site; EUR 45,000 - 70,000; Full time

Job summary

Bristol Myers Squibb in Leiden, Netherlands, is seeking a Specialist, QC Analytical to support in-process, final product, and stability testing, with data review and verification responsibilities.

The role may involve method transfer, deviations, investigations, CAPA, and continuous improvement, with training of analysts and collaboration across teams. A science background and experience in regulated environments are valued.

Qualifications

• 2+ years of analytical testing or QC experience in a regulated environment.
• Experience with analytical techniques (e.g., HPLC/UPLC, qPCR, ELISA) preferred.
• Ability to understand and apply Global Regulatory and cGMP requirements.
• Effective communication with peers and management.
• Experience writing technical documents.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform deviations/investigations and CAPA and continuous improvement tasks.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Skills

Regulatory compliance

Quality control

Data analysis

Communication

Technical writing

Team collaboration

Education

Bachelor's degree in science

Tools

LIMS

ELN

Job description

Bristol Myers Squibb in Leiden, Netherlands, is seeking a Specialist, QC Analytical to support in-process, final product, and stability testing, with data review and verification responsibilities.

The role may involve method transfer, deviations, investigations, CAPA, and continuous improvement, with training of analysts and collaboration across teams. A science background and experience in regulated environments are valued.