Cell Therapy QC Analyst - In-Process & Final Product

Regulatory Jobs; New Jersey; In loco; USD 47.000 - 58.000; Tempo pieno

Descrizione del lavoro

Bristol Myers Squibb in Summit West, NJ is seeking a Specialist, QC Analytical, Cell Therapy to support in-process, final product and stability testing, including data review and verification. You may assist with method transfer, deviations, investigations, and continuous improvement efforts.

Shift: Wed–Sat, 1:30pm–11:30pm. The role involves documenting GMP activities, training analysts, and collaborating with cross-functional teams in a fast-paced environment.

Competenze

• Bachelor's degree in science or equivalent.
• 2+ years of analytical testing or QC in a regulated env.
• Experience with cell and molecular biology techniques.
• Knowledge of LIMS, ELN and lab data analysis systems.
• Ability to follow Global Regulatory and cGMP requirements.
• Strong communication and teamwork in fast-paced settings.

Mansioni

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer/validation/verification.
• Perform data verification and review GMP documentation.
• Assist with document revision, CAPA and deviation/investigation tasks.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Conoscenze

Regulatory & cGMP comprehension

LIMS/ELN knowledge

Problem solving

Effective communication

Technical documentation writing

Teamwork in fast-paced env

Formazione

Bachelor's degree in science

2+ years QC/analytical testing

Cell/molecular biology techniques

Strumenti

LIMS

ELN

Descrizione del lavoro

Bristol Myers Squibb in Summit West, NJ is seeking a Specialist, QC Analytical, Cell Therapy to support in-process, final product and stability testing, including data review and verification. You may assist with method transfer, deviations, investigations, and continuous improvement efforts.

Shift: Wed–Sat, 1:30pm–11:30pm. The role involves documenting GMP activities, training analysts, and collaborating with cross-functional teams in a fast-paced environment.