Associate Technical Writer, MTS CAR-T Manufacturing In Summit, NJ
About the position
The Associate Technical Writer, MTS CAR-T Manufacturing at Bristol Myers Squibb will play a crucial role in supporting the manufacturing process of CAR-T cell therapy. This position involves collaboration with various internal teams to ensure compliance with quality standards and timely completion of documentation related to manufacturing operations. The role focuses on writing, revising, and reviewing GMP documentation, as well as managing deviations, CAPAs, and change controls to enhance operational efficiency and maintain regulatory compliance.
Responsibilities
• Attend alignment meetings and evaluate severity classification of deviations.
,
• Handle no Impact deviations requiring rapid turnaround.
,
• Create and review QMS deviations, ensuring timelines are met.
,
• Complete investigations for minor deviations.
,
• Open CAPAs to revise SOPs and Work Instructions for new product/process implementation.
,
• Complete CAPA Actions within QMS and conduct effectiveness checks.
,
• Ensure on-time closure of CAPAs and Effectiveness Checks.
,
• Complete change control actions within EQMS as needed.
,
• Work cross-functionally to update procedures and documents for procedural gaps.
,
• Drive continuous improvement to reduce human avoidable deviations.
Requirements
• Bachelor's degree with ability to learn Manufacturing Technical Writing skills.
,
• OR Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience.
,
• OR High School diploma/GED and 2 years of Manufacturing or Operations experience with emphasis on Technical Writing and/or QA role.
,
• Knowledge of cGMP manufacturing, Quality, FDA, and compliance.
,
• Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
,
• Strong technical and compliance writing capability.
,
• Proficient in MS Office applications.
Nice-to-haves
• Background in biology, chemistry, medical or clinical practices.
,
• Excellent verbal and written communication skills.
,
• Ability to effectively multi-task.
Benefits
• Competitive salary and benefits package.
,
• Opportunities for professional growth and development.
,
• Flexible work environment.
Apply Now
The Associate Technical Writer, MTS CAR-T Manufacturing at Bristol Myers Squibb will play a crucial role in supporting the manufacturing process of CAR-T cell therapy. This position involves collaboration with various internal teams to ensure compliance with quality standards and timely completion of documentation related to manufacturing operations. The role focuses on writing, revising, and reviewing GMP documentation, as well as managing deviations, CAPAs, and change controls to enhance operational efficiency and maintain regulatory compliance.
Responsibilities
• Attend alignment meetings and evaluate severity classification of deviations.
,
• Handle no Impact deviations requiring rapid turnaround.
,
• Create and review QMS deviations, ensuring timelines are met.
,
• Complete investigations for minor deviations.
,
• Open CAPAs to revise SOPs and Work Instructions for new product/process implementation.
,
• Complete CAPA Actions within QMS and conduct effectiveness checks.
,
• Ensure on-time closure of CAPAs and Effectiveness Checks.
,
• Complete change control actions within EQMS as needed.
,
• Work cross-functionally to update procedures and documents for procedural gaps.
,
• Drive continuous improvement to reduce human avoidable deviations.
Requirements
• Bachelor's degree with ability to learn Manufacturing Technical Writing skills.
,
• OR Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience.
,
• OR High School diploma/GED and 2 years of Manufacturing or Operations experience with emphasis on Technical Writing and/or QA role.
,
• Knowledge of cGMP manufacturing, Quality, FDA, and compliance.
,
• Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
,
• Strong technical and compliance writing capability.
,
• Proficient in MS Office applications.
Nice-to-haves
• Background in biology, chemistry, medical or clinical practices.
,
• Excellent verbal and written communication skills.
,
• Ability to effectively multi-task.
Benefits
• Competitive salary and benefits package.
,
• Opportunities for professional growth and development.
,
• Flexible work environment.
Apply Now