GMP Technical Writer for Quality & Compliance

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 72,000 - 87,000; Full time

Job summary

Bristol Myers Squibb in Summit West NJ is seeking a Manufacturing Technical Writing associate to support Deviations, CAPAs and Change Controls. You will write, revise and review GMP documentation and collaborate with MO, QA, MSAT and other groups to ensure timely action closures.

The role emphasizes independent work, strong writing skills, and the ability to manage multiple tasks in a fast-paced manufacturing environment. On-site work and comprehensive benefits are highlighted.

Qualifications

• Must have knowledge of cGMP Manufacturing and/or Quality.
• Must be able to work independently and with critical thinking mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Excellent verbal and written communication skills.
• Knowledge of cGMP and FDA regulated industry.
• Strong technical and compliance writing capability.
• Proficient in MS Office applications.

Responsibilities

• Attend alignment meetings.
• Create and/or review QMS deviations, provide feedback when needed, and ensure timelines are met.
• Complete investigations for deviations.
• Responsible for opening CAPAs as needed.
• Ability to complete effectiveness checks.
• Ensure on-time closure of CAPAs and Effectiveness Checks for the MO organization.
• Ability to work cross-functionally to make necessary updates to documents.
• Ability to complete change control actions within QMS as needed.
• Responsible for on-time closure of Change Controls Actions for the MO organization.
• Facilitate pre-CCRB meetings and attend CCRB.
• Ability to open Change Controls and associated actions.
• Human avoidable deviation reduction driven with continuous improvement.
• Ability to collaborate with Manufacturing Operations, QA, MSAT, and other groups to verify the correct reviewers and approvers are selected.
• Ensuring on time completion for all actions of the MO organization.
• Other duties may be assigned, as necessary.
• Ability to project manage QMS records.

Skills

cGMP knowledge

Independent thinking

Multitasking

Written communication

Regulatory writing

MS Office

Education

Bachelor’s degree

Associate/Medical Technical degree

High School diploma/GED

Tools

MS Office

Job description

Bristol Myers Squibb in Summit West NJ is seeking a Manufacturing Technical Writing associate to support Deviations, CAPAs and Change Controls. You will write, revise and review GMP documentation and collaborate with MO, QA, MSAT and other groups to ensure timely action closures.

The role emphasizes independent work, strong writing skills, and the ability to manage multiple tasks in a fast-paced manufacturing environment. On-site work and comprehensive benefits are highlighted.