Supply Chain Technical Writer II

About the role

Develop and update processing documentation for manufacturing operations and facilitate CAPA closures within Supply Chain. Author SOPs, work instructions, specifications, and work instructions, and provide associated documentation through the various change management processes. Actively participate in the authoring of Operations related process improvement initiatives.

Responsibilities

• Partner with SMEs in the Supply Chain team in creating or revising various GMP documents, including SOPs, forms, work instructions, specifications, Change Controls, etc.
• Develop standards for type of content and formatting of SOPs and other documents.
• Ensure logical organization of documents, while minimizing gaps and duplication.
• Partner with counterparts of Supply Chain to ensure consistency of type of content and formatting for GMP documents.
• Coordinate with the Quality group to ensure all GMP documents for Operations meet or exceed compliance expectations.
• Compile supporting documentation and ensure all change management requirements for GMP documentation are met.
• Follow up with reviewers and approvers for timely completion.
• Work closely with Supply Chain personnel for scheduling and completing documentation process related activities.
• Participate in change planning, meeting facilitation and management, change proposal review, developing communications and leveraging employee feedback and data for improvement.
• Actively participate in the authoring of Operations related process improvement initiatives.

Qualifications

• Bachelor’s degree in a scientific discipline or 5+ years of equivalent experience.
• Strong oral and written communication skills.
• 3‑6 years of relevant experience in a pharmaceutical manufacturing‑related field.
• Previous technical writing and/or training experience preferred.
• Ability to communicate effectively with all levels of the organization.
• Demonstrated creative thinking skills.
• Proficiency with Microsoft Office applications (Word, Excel, Access, PowerPoint).
• Experience with advanced document management applications (a plus).
• Experience with process improvement systems and techniques.