TPS Group Company is hiring: Technical Documentation Writer in Northridge
TPS Group Company, Northridge, CA, United States
Technical Documentation Writer
Location: Onsite | Bridgeton, MO 63044
Department: Compliance / Manufacturing Support
Reports To: Compliance Manager - Aseptic Operations
Position Summary
The Technical Documentation Writer is responsible for authoring, revising, and maintaining controlled GMP documentation to ensure accuracy, clarity, regulatory compliance, and operational effectiveness. This role supports aseptic manufacturing operations by developing and improving standard operating procedures (SOPs), batch records, forms, and training materials. The ideal candidate combines strong technical writing expertise with knowledge of pharmaceutical quality systems and human performance principles to drive right-first-time documentation execution.
Key Responsibilities
Basic Qualifications
Location: Onsite | Bridgeton, MO 63044
Department: Compliance / Manufacturing Support
Reports To: Compliance Manager - Aseptic Operations
Position Summary
The Technical Documentation Writer is responsible for authoring, revising, and maintaining controlled GMP documentation to ensure accuracy, clarity, regulatory compliance, and operational effectiveness. This role supports aseptic manufacturing operations by developing and improving standard operating procedures (SOPs), batch records, forms, and training materials. The ideal candidate combines strong technical writing expertise with knowledge of pharmaceutical quality systems and human performance principles to drive right-first-time documentation execution.
Key Responsibilities
- Author, revise, and maintain Standard Operating Procedures (SOPs), batch records, forms, and on-the-job training (OJT) skill assessments.
- Ensure documentation complies with company policies, Good Manufacturing Practices (GMP), and applicable regulatory requirements.
- Observe manufacturing processes and collaborate with subject matter experts to ensure procedural accuracy and clarity.
- Apply human performance principles and technical writing best practices to improve document usability and reduce execution errors.
- Lead and support continuous improvement initiatives related to GMP documentation.
- Manage document projects and ensure deliverables are completed according to established timelines.
- Monitor and report documentation metrics to identify trends and drive improvements.
- Collaborate cross-functionally with Manufacturing, Quality, Validation, Regulatory, and Environmental Health & Safety (EHS) teams.
- Conduct training sessions (classroom and on-the-job) as required.
- Track and communicate document status for key site projects.
Basic Qualifications
- Associate degree in Life Sciences, Education/Training, or related discipline (or equivalent combination of education and experience).
- 1-2 years of experience in pharmaceutical manufacturing or regulated industry environment.
- Knowledge of Quality Systems and GMP documentation requirements.
- Strong technical writing experience with instructional or procedural documentation.
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio) and Adobe Acrobat.
- Experience creating and managing complex Word templates (including formatting tables, images, shapes, and embedded elements).
- Excellent project management and organizational skills.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple priorities.
- Experience supporting aseptic processing environments.
- Background in instructional design or technical training.