Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support
Bristol Myers Squibb
August 13, 2026
Remote friendly (Summit, NJ)
United States
Operations
Position Summary:
Collaborate with Manufacturing partners (MSAT, Warehouse, EHS, Quality) to support improvement actions (Deviations, CAPAs, Change Control, document updates). Work with Manufacturing Operations (MO) and Quality teams on CAPAs and Change Controls to ensure on-time implementation. Write, revise, and review GMP documentation for S12 CAR T manufacturing.
Duties/Responsibilities:
- Deviations: Attend alignment meetings; create/review QMS deviations; provide feedback; meet timelines; complete deviation investigations.
- CAPAs: Open CAPAs as needed; complete effectiveness checks; ensure on-time closure of CAPAs and effectiveness checks; update documents cross-functionally.
- Change Controls: Complete change control actions in QMS; ensure on-time closure for MO; facilitate pre-CCRB meetings and attend CCRB; open change controls/actions.
- Continuous Improvement: Reduce human-avoidable deviations via continuous improvement.
Required For All Job Functions:
- Collaborate to verify correct reviewers/approvers; ensure on-time MO action completion; project-manage QMS records.
Qualifications:
- Knowledge of cGMP Manufacturing and/or Quality; cGMP and FDA-regulated industry.
- Ability to work independently with critical thinking; moderate direction for complex tasks.
- Strong verbal/written communication; technical/compliance writing; MS Office proficiency.
- Ability to multi-task, recognize conflict, and communicate problems clearly.
Education/Experience:
- Bachelor’s degree (with ability to learn Manufacturing Technical Writing), or
- Associate/Medical Technical degree + 1–2 years manufacturing/operations, or
- HS diploma/GED + 2 years manufacturing/operations with emphasis on technical writing and/or QA.
Benefits (explicitly listed):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k); disability; life/accident; supplemental health; business travel protection; personal liability; identity theft; legal support; survivor support.
- Paid time off (flexible time off or specified vacation/holidays depending on location).
Collaborate with Manufacturing partners (MSAT, Warehouse, EHS, Quality) to support improvement actions (Deviations, CAPAs, Change Control, document updates). Work with Manufacturing Operations (MO) and Quality teams on CAPAs and Change Controls to ensure on-time implementation. Write, revise, and review GMP documentation for S12 CAR T manufacturing.
Duties/Responsibilities:
- Deviations: Attend alignment meetings; create/review QMS deviations; provide feedback; meet timelines; complete deviation investigations.
- CAPAs: Open CAPAs as needed; complete effectiveness checks; ensure on-time closure of CAPAs and effectiveness checks; update documents cross-functionally.
- Change Controls: Complete change control actions in QMS; ensure on-time closure for MO; facilitate pre-CCRB meetings and attend CCRB; open change controls/actions.
- Continuous Improvement: Reduce human-avoidable deviations via continuous improvement.
Required For All Job Functions:
- Collaborate to verify correct reviewers/approvers; ensure on-time MO action completion; project-manage QMS records.
Qualifications:
- Knowledge of cGMP Manufacturing and/or Quality; cGMP and FDA-regulated industry.
- Ability to work independently with critical thinking; moderate direction for complex tasks.
- Strong verbal/written communication; technical/compliance writing; MS Office proficiency.
- Ability to multi-task, recognize conflict, and communicate problems clearly.
Education/Experience:
- Bachelor’s degree (with ability to learn Manufacturing Technical Writing), or
- Associate/Medical Technical degree + 1–2 years manufacturing/operations, or
- HS diploma/GED + 2 years manufacturing/operations with emphasis on technical writing and/or QA.
Benefits (explicitly listed):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k); disability; life/accident; supplemental health; business travel protection; personal liability; identity theft; legal support; survivor support.
- Paid time off (flexible time off or specified vacation/holidays depending on location).