Associate Technical Writer - GMP Deviations & CAPA Support

Bristol Myers Squibb; Summit (NJ); On-site; USD 95,000 - 135,000; Full time

Job summary

Bristol Myers Squibb seeks an associate to collaborate with internal Manufacturing partners, such as MSAT, Warehouse, Environmental Health and Safety (EHS) and Quality, to support improvement actions (Deviations, CAPAs, Change Control and Document updates).

The associate will work with MO and Quality teams on CAPAs and Change Controls to ensure on-time implementation and maintain GMP documents for S12 CAR T manufacturing.

Qualifications

• Experience handling GMP deviations and CAPAs.
• Ability to review and update QMS documents.
• Cross-functional collaboration with MO, QA, MSAT to ensure on-time closures.

Responsibilities

• Attend alignment meetings and review deviations.
• Open and close CAPAs with effectiveness checks.
• Complete change control actions and ensure timely closures.

Skills

Deviations management

CAPAs

Change controls

Job description

Bristol Myers Squibb seeks an associate to collaborate with internal Manufacturing partners, such as MSAT, Warehouse, Environmental Health and Safety (EHS) and Quality, to support improvement actions (Deviations, CAPAs, Change Control and Document updates).

The associate will work with MO and Quality teams on CAPAs and Change Controls to ensure on-time implementation and maintain GMP documents for S12 CAR T manufacturing.