Associate Technical Writer, Manufacturing Technical Support
About the position The Associate Technical Writer in Manufacturing Technical Support at Bristol Myers Squibb plays a crucial role in supporting the completion of improvement actions within the manufacturing environment. This position involves collaboration with various internal partners, including Manufacturing Science & Technology (MS&T), Warehouse, Environmental Health and Safety (EHS), and Quality groups. The Associate will be responsible for collecting information from triage and initiating records in the Quality Management System (QMS), ensuring that all necessary documentation is accurate and up-to-date. This includes supporting No Impact Deviations and working closely with the Manufacturing Operations (MO) and Quality Assurance (QA) teams on Corrective and Preventive Actions (CAPAs) and Change Control Actions, ensuring timely implementation and closure of these actions. In addition to these responsibilities, the Associate will write, revise, and review all related Good Manufacturing Practice (GMP) documentation for S12 CAR T manufacturing records and procedures, including Standard Operating Procedures (SOPs) and Work Instructions. The role requires attending alignment meetings to evaluate and provide feedback on severity classification of deviations, handling no Impact deviations with rapid turnaround, and ensuring that timelines for QMS deviations are met. The Associate will also be responsible for opening CAPAs as needed, completing effectiveness checks, and working cross-functionally to address procedural gaps. The position is primarily office-based but may require some interactions in clean room environments, which are enclosed spaces with specific pressure and temperature conditions. The work environment is designed to minimize noise and distractions, allowing for efficient communication and productivity. Employees are encouraged to take short walks to promote ergonomics and well-being. This role is essential in driving continuous improvement initiatives and ensuring compliance with cGMP and FDA regulations, ultimately contributing to the mission of transforming patients' lives through science.
Responsibilities
- Attend alignment meetings and evaluate severity classification of deviations.
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- Handle no Impact deviations requiring rapid turnaround.
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- Create and review QMS deviations, providing feedback and ensuring timelines are met.
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- Open CAPAs as needed to revise SOPs and Work Instructions for new product/process implementation.
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- Complete CAPA Actions within QMS and conduct effectiveness checks as required.
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- Work cross-functionally to update procedures/documents addressing procedural gaps.
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- Complete change control actions within EQMS as needed.
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- Ensure on-time closure of Change Control Actions.
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- Drive continuous improvement initiatives to reduce human avoidable deviations.
Requirements
- Bachelor's degree with ability to learn Manufacturing Technical Writing skills.
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- OR Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience.
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- OR High School diploma/GED and 2 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.
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- Knowledge of cGMP manufacturing, Quality, FDA, and compliance.
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- Understanding of US and global cGMP requirements.
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- Strong technical and compliance writing capability.
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- Excellent verbal and written communication skills.
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- Basic mathematical skills.
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- Proficient in MS Office applications.
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- Background in biology, chemistry, medical, or clinical practices.
Nice-to-haves
- Experience in a cGMP/FDA regulated industry.
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- Ability to work independently with moderate direction for complex tasks.
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- Experience in cross-functional collaboration and conflict resolution.
Benefits
- Competitive salary and benefits package.
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- Opportunities for professional development and career growth.
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- Flexible work environment with a focus on work-life balance.
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