CAR-T GMP Technical Writer – Deviation & CAPA Support

Bristol-Myers Squibb; Summit (NJ); Hybrid; USD 48,000 - 58,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Work-life benefits

Job summary

Bristol Myers Squibb in Summit, NJ is seeking an Associate Technical Writer (Deviation Assessment) to support CAR-T manufacturing. You will collaborate with MSAT, MO, QA and EHS to produce, revise, and review GMP documentation including deviations, CAPAs and change controls, ensuring on-time implementation.

The role requires strong cGMP knowledge and writing skills, ability to multi-task, and effective cross-functional communication.

Qualifications

• Bachelor’s degree or equivalent with ability to learn Manufacturing Technical Writing.
• 1–2 years of Manufacturing or Operations experience (alternate paths acceptable).
• Strong writing and editing of GMP/regulated documents.

Responsibilities

• Assist deviations: attend alignment meetings and review deviations; ensure timelines.
• Open and close CAPAs; perform effectiveness checks and document updates.
• Manage Change Controls and CCRB meetings; ensure on-time closure.
• Collaborate across MO, QA, MSAT to verify correct reviewers and approvers.
• Project-manage QMS records and ensure compliance across docs.

Skills

cGMP knowledge

Technical writing

MS Office

Communication

Critical thinking

Cross-functional collaboration

Education

Bachelor’s degree or higher

Associate/ Medical Technical degree

High School diploma + 2 years experience

Tools

MS Office

QMS documentation systems

Job description

Bristol Myers Squibb in Summit, NJ is seeking an Associate Technical Writer (Deviation Assessment) to support CAR-T manufacturing. You will collaborate with MSAT, MO, QA and EHS to produce, revise, and review GMP documentation including deviations, CAPAs and change controls, ensuring on-time implementation.

The role requires strong cGMP knowledge and writing skills, ability to multi-task, and effective cross-functional communication.