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, and document updates).
- Work with Manufacturing Operations (MO) and Quality on CAPAs and Change Controls; 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 and provide feedback; complete deviation investigations; ensure timelines.
- CAPAs: open CAPAs as needed; complete effectiveness checks; ensure on-time closure for MO; update documents cross-functionally.
- Change Controls: complete QMS change control actions; ensure on-time closure for MO; facilitate pre-CCRB meetings and attend CCRB; open change controls and associated actions.
- Continuous Improvement: drive human-avoidable deviation reduction.
Required For All Job Functions:
- Collaborate with MO, QA, MSAT, and others to verify correct reviewers/approvers.
- Ensure on-time completion of MO actions.
- Project manage QMS records; other duties as assigned.
Qualifications:
- Knowledge of cGMP Manufacturing and/or Quality; cGMP and FDA-regulated industry knowledge.
- Ability to work independently with critical thinking; moderate direction for complex tasks.
- Strong verbal/written communication; technical and compliance writing.
- Ability to multi-task, recognize conflict, and propose resolution.
- Proficient in MS Office.
Education/Experience:
- Bachelor’s degree (learn Manufacturing Technical Writing skills) OR
- Associate/Medical Technical degree + 1–2 years Manufacturing/Operations OR
- High school/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 insurance, supplemental health, and other listed protection.
- Paid Time Off (flexible time off or 160 hours vacation depending on group); 11 paid national holidays; possible additional time off based on eligibility.
Compensation Overview (explicitly listed):
- $34.66–$42.00 per hour (Summit West - NJ - US).
- Collaborate with Manufacturing partners (MSAT, Warehouse, EHS, Quality) to support improvement actions (Deviations, CAPAs, Change Control, and document updates).
- Work with Manufacturing Operations (MO) and Quality on CAPAs and Change Controls; 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 and provide feedback; complete deviation investigations; ensure timelines.
- CAPAs: open CAPAs as needed; complete effectiveness checks; ensure on-time closure for MO; update documents cross-functionally.
- Change Controls: complete QMS change control actions; ensure on-time closure for MO; facilitate pre-CCRB meetings and attend CCRB; open change controls and associated actions.
- Continuous Improvement: drive human-avoidable deviation reduction.
Required For All Job Functions:
- Collaborate with MO, QA, MSAT, and others to verify correct reviewers/approvers.
- Ensure on-time completion of MO actions.
- Project manage QMS records; other duties as assigned.
Qualifications:
- Knowledge of cGMP Manufacturing and/or Quality; cGMP and FDA-regulated industry knowledge.
- Ability to work independently with critical thinking; moderate direction for complex tasks.
- Strong verbal/written communication; technical and compliance writing.
- Ability to multi-task, recognize conflict, and propose resolution.
- Proficient in MS Office.
Education/Experience:
- Bachelor’s degree (learn Manufacturing Technical Writing skills) OR
- Associate/Medical Technical degree + 1–2 years Manufacturing/Operations OR
- High school/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 insurance, supplemental health, and other listed protection.
- Paid Time Off (flexible time off or 160 hours vacation depending on group); 11 paid national holidays; possible additional time off based on eligibility.
Compensation Overview (explicitly listed):
- $34.66–$42.00 per hour (Summit West - NJ - US).