CAR-T Manufacturing Technical Writer: Deviations & CAPAs

Bristol-Myers Squibb; Summit (NJ); On-site; USD 72,000 - 87,000; Full time

Benefits offered by this job

Health Coverage: Medical, pharmacy, &

Dental & vision care

Life insurance

401(k) with company match

Paid holidays & time off

Job summary

Bristol Myers Squibb is seeking an Associate Technical Writer to support deviation assessments in CAR-T manufacturing. The role involves collaborating with MO, QA, MSAT and other groups to ensure on-time closures of CAPAs and change controls.

You will write and review GMP documentation and participate in cross-functional teams. On-site role with a focus on quality and regulatory compliance, requiring strong technical writing and communication skills and the ability to manage multiple tasks

Qualifications

• Knowledge of cGMP Manufacturing and/or Quality.
• Excellent written and verbal communication skills.
• Proficient in MS Office applications.

Responsibilities

• Collaborate with MO, QA, MSAT and other groups to ensure correct reviewers and approvers.
• Open CAPAs and ensure timely closure of actions.
• Complete change control actions within QMS and facilitate CCRB meetings.
• Write, revise and review GMP documentation for CAR-T manufacturing.

Skills

cGMP Manufacturing

Quality

Verbal and written communication

MS Office

multitasking

Education

Bachelor’s degree in Manufacturing/Technical Writing

Associate/ Medical Technical degree

High School diploma/GED

Tools

MS Office

Job description

Bristol Myers Squibb is seeking an Associate Technical Writer to support deviation assessments in CAR-T manufacturing. The role involves collaborating with MO, QA, MSAT and other groups to ensure on-time closures of CAPAs and change controls.

You will write and review GMP documentation and participate in cross-functional teams. On-site role with a focus on quality and regulatory compliance, requiring strong technical writing and communication skills and the ability to manage multiple tasks