GMP Technical Writer & Quality Documentation Associate

Biopharma Careers; Summit West (CA); On-site; USD 99,315,000 - 120,347,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Manufacturing Quality Support professional to collaborate with MO, QA, MSAT, and other groups. The role focuses on deviations, CAPAs, and change controls while ensuring timely completion and cross-functional updates.

The candidate should have a strong understanding of cGMP, be able to work independently, multi-task, and communicate clearly in written form, with emphasis on quality documentation and regulatory compliance.

Qualifications

• Must have knowledge of cGMP Manufacturing and/or Quality.
• Requires independent work with critical thinking.

Responsibilities

• Attend alignment meetings and review deviations; ensure timelines are met.
• Open CAPAs and ensure on-time closure for MO.
• Complete change control actions within QMS and CCRB attendance.

Skills

cGMP knowledge

Independent work

Multi-tasking

Written communication

Problem solving

Education

Bachelor’s degree

Associate/Medical Tech degree

High School diploma/GED

Tools

MS Office

Job description

Bristol Myers Squibb is seeking a Manufacturing Quality Support professional to collaborate with MO, QA, MSAT, and other groups. The role focuses on deviations, CAPAs, and change controls while ensuring timely completion and cross-functional updates.

The candidate should have a strong understanding of cGMP, be able to work independently, multi-task, and communicate clearly in written form, with emphasis on quality documentation and regulatory compliance.