Manufacturing Technical Writer

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

• Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products
• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills
• Strong technical and compliance writing capability
• Proficient in MS Office applications
• Background to include an understanding of biology, chemistry, medical or clinical practices
• Previous experience leading and closing deviation investigations to support lot release

Education and Experience:

• Bachelor’s degree plus 2-4  years of experience in Manufacturing Technical Writing or in a QA role
• OR Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience
• OR High School diploma/GED and 10 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA

DUTIES AND RESPONSIBILITIES:

• Lead Manufacturing NOEs and deviation investigations to ensure on time closure
• Responsible for opening change controls as needed to revise Batch Records, SOPs, Work Instructions to support new product/process implementation, and close CAPAs
• Participate in cross-functional deviation and CAPA meetings and initiatives in S12
• Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to appropriately assign deviation investigations and CAPAs, and support closure
• Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations
• Other duties may be assigned, as necessary