Medasource
Seeking a Technical Writer to support Manufacturing Process teams by authoring, reviewing, and releasing GMP documentation. This role is critical to enabling efficient manufacturing operations, supporting product re‑introductions, and new product introductions (NPIs).
Key Responsibilities
Author, revise, review, and release GMP documentation, including Process Batch Records, SOPs, and Forms, using Veeva Vault
Ensure production documentation aligns with Technology Transfer documents and is available on time to support manufacturing operations
Support Manufacturing Process teams across multiple functional areas, with an initial focus on utilities equipment, while concurrently developing procedures for process equipment
Collaborate cross‑functionally with Manufacturing, Process Engineering, TS/MS, QA, QC, and Logistics
Identify content best suited for training materials and apply adult learning principles
Proactively recommend improvements to document structure, clarity, and usability to enhance manufacturing performance
Develop procedures and supporting materials that promote operational consistency and right‑first‑time execution
Qualifications
Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or related field
Experience authoring GMP documentation in a regulated manufacturing environment
Hands‑on experience with Veeva Vault or similar document management systems
Strong ability to write clear, concise procedures for diverse audiences
Highly collaborative with strong time‑management skills
Preferred
Experience with utilities or process equipment documentation
Exposure to clinical and/or commercial manufacturing environments
Familiarity with training‑aligned documentation and adult learning concepts
Seniority level Associate
Employment type Full‑time
Job function Writing/Editing and Project Management
Industries Hospitals and Health Care, Pharmaceutical Manufacturing, and Biotechnology Research
Benefits
Medical insurance
Vision insurance
Location: Indianapolis, IN
Salary: $15.00-$15.00
Posted 8 hours ago
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Key Responsibilities
Author, revise, review, and release GMP documentation, including Process Batch Records, SOPs, and Forms, using Veeva Vault
Ensure production documentation aligns with Technology Transfer documents and is available on time to support manufacturing operations
Support Manufacturing Process teams across multiple functional areas, with an initial focus on utilities equipment, while concurrently developing procedures for process equipment
Collaborate cross‑functionally with Manufacturing, Process Engineering, TS/MS, QA, QC, and Logistics
Identify content best suited for training materials and apply adult learning principles
Proactively recommend improvements to document structure, clarity, and usability to enhance manufacturing performance
Develop procedures and supporting materials that promote operational consistency and right‑first‑time execution
Qualifications
Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or related field
Experience authoring GMP documentation in a regulated manufacturing environment
Hands‑on experience with Veeva Vault or similar document management systems
Strong ability to write clear, concise procedures for diverse audiences
Highly collaborative with strong time‑management skills
Preferred
Experience with utilities or process equipment documentation
Exposure to clinical and/or commercial manufacturing environments
Familiarity with training‑aligned documentation and adult learning concepts
Seniority level Associate
Employment type Full‑time
Job function Writing/Editing and Project Management
Industries Hospitals and Health Care, Pharmaceutical Manufacturing, and Biotechnology Research
Benefits
Medical insurance
Vision insurance
Location: Indianapolis, IN
Salary: $15.00-$15.00
Posted 8 hours ago
#J-18808-Ljbffr