GMP Technical Writer - CAPA, Deviations & Change Controls

Bristol-Myers Squibb; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manufacturing Technical Writer to support Deviations, CAPAs, and Change Controls. You will draft, revise, and review GMP documentation, ensuring on-time completion and accuracy while collaborating with Manufacturing Operations, QA, and MSAT teams.

Ideal candidates have strong written communication skills, the ability to multi-task, and experience with quality systems. On-site role with cross-functional interactions in a fast-paced environment.

Qualifications

• Must have knowledge of cGMP Manufacturing and/or Quality.
• Requires independent work with critical thinking mindset.
• Ability to project manage QMS records and collaborate cross-functionally.

Responsibilities

• Attend alignment meetings and review QMS deviations.
• Open CAPAs and ensure timely closure and effectiveness checks.
• Complete change control actions within QMS and coordinate with MO.
• Drive continuous improvement and reduce human avoidable deviations.
• Collaborate with MO, QA, MSAT and other groups to verify reviewers/approvers.

Skills

cgmp manufacturing knowledge

quality mindset

critical thinking

written communication

multitasking

Education

Bachelor's degree (Manufacturing/Technical Writing)

Associate/Medical Technical degree + 1–2 years experience

High School diploma + 2 years experience in Manufacturing/QA

Tools

MS Office

Job description

Bristol Myers Squibb is seeking a Manufacturing Technical Writer to support Deviations, CAPAs, and Change Controls. You will draft, revise, and review GMP documentation, ensuring on-time completion and accuracy while collaborating with Manufacturing Operations, QA, and MSAT teams.

Ideal candidates have strong written communication skills, the ability to multi-task, and experience with quality systems. On-site role with cross-functional interactions in a fast-paced environment.